Speakers - 2017 Next Generation Dx Summit

2017 Archived Content

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Speaker Biographies

Plenary Keynote Session

Michael J. Bennett, Ph.D., FRCPath, FACB, DABCC, President, AACC; Professor, Pathology & Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania; Evelyn Willing Bromley Endowed Chair in Clinical Laboratories & Pathology; Chief, Division of Laboratory Medicine; Director, Clinical Chemistry & Metabolic Disease Laboratories, The Children’s Hospital of Philadelphia

Michael J. Bennett Ph.D., FRCPath, DABCC, FACB, is a Professor of Pathology and Laboratory Medicine at the University of Pennsylvania and Chief of Laboratory Medicine at The Children’s Hospital of Philadelphia. He holds the Evelyn Willing Bromley Endowed Chair in Clinical Laboratories and Pathology. He obtained his Ph.D. at the University of Sheffield School of Medicine, UK in the field of Medical Enzymology. Dr. Bennett has been actively involved with AACC at all levels. He is past chair of the Texas section and of the Pediatric and Maternal-Fetal division of AACC. He is Past President of the National Academy of Clinical Biochemistry (NACB) and is the immediate past-treasurer of AACC and current AACC President.

Andrew C. Fish, J.D., Chief Strategy Officer, AdvaMed; Executive Director, AdvaMedDx

Andrew Fish is Chief Strategy Officer of AdvaMed, the leading trade association advancing medical technology in the U.S. and around the world. As chief strategy officer, Mr. Fish leads the association’s strategic planning, manages AdvaMed's global, regulatory, and payment departments, and coordinates the development and operations of AdvaMed’s membership divisions and sectors. Mr. Fish also serves as Executive Director of AdvaMedDx, AdvaMed’s diagnostics division that operates as the U.S. trade association representing leading manufacturers of medical diagnostic tests. Mr. Fish joined AdvaMedDx upon its founding in 2010 and led the development of AdvaMedDx into a globally influential advocacy organization.

Mr. Fish has extensive experience navigating the complex intersections of business, science, media, law, regulation, and politics. Prior to joining AdvaMedDx, Mr. Fish was Senior Vice President of Legal and Government Affairs, General Counsel, and Secretary for the Consumer Healthcare Products Association (CHPA), representing manufacturers of non-prescription medicines. Mr. Fish also led the American Cancer Society’s federal lobbying team as the Senior Director of Federal Government Relations. Earlier in Mr. Fish’s career, he served in the Senate-confirmed post of Assistant Secretary of Agriculture for Congressional and Intergovernmental Affairs. Prior to that position, he worked twice for the U.S. Senate Agriculture Committee, first as a professional staff member and later as deputy chief counsel.

In his legal practice, Mr. Fish focused on biotechnology regulation, as well as on a wide range of food, drug and agriculture issues. Mr. Fish is a graduate of Yale University and Stanford Law School.

Christine C. Ginocchio, Ph.D., MT (ASCP), Vice President, Global Microbiology Affairs, bioMérieux; Vice President, Scientific and Medical Affairs, BioFire; Professor, Hofstra North Shore-LIJ School of Medicine

Christine C. Ginocchio, Ph.D., MT (ASCP) is the VP, Global Microbiology Affairs, bioMérieux, NC and Professor of Medicine, Hofstra North Shore-LIJ School of Medicine, NY. Previously, she was Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, North Shore-LIJ Health System Laboratories, NY. She has 40 years’ experience in clinical diagnostics and has been the principal investigator for more than 60 industry and pharmaceutical clinical trials. Dr. Ginocchio’s areas of extra-mural funded research have included HIV, CMV, respiratory viruses, HPV, antibiotic resistance and molecular diagnostics for infectious diseases. Her awards include the President’s Award and Irving Abrahams Award for outstanding basic science research, the PASCV 2012 award in Diagnostic Virology and the ASM 2013 BD Award for Research in Clinical Microbiology. She is currently the Co-Editor-in-Chief for the Journal of Clinical Virology. Dr. Ginocchio has published 9 book chapters, over 225 peer-reviewed articles/abstracts and has been an invited speaker at over 200 national and international conferences.

Kevin Hrusovsky, Chairman & CEO, Quanterix

Kevin joined Quanterix in 2014 and serves as the Chief Executive Officer and Executive Chairman. While at Quanterix, Kevin has led the Company to achieve significant success and growth, recently securing a $46 million capital raise that elevated the Company’s valuation to ten times its revenue. With over 25 years of experience in the life sciences space, he has dedicated his career to transforming healthcare into personalized medicine, and has a proven track record of commercializing disruptive technologies. Kevin currently serves on the Board of Directors of several companies transforming the future of precision health, including Quanterix, BioreclamationIVT, Cellaria, Cell Signaling Technology, 908 Devices, SynapDx and Solect Energy, and is the founder of the Powering Precision Health Summit. He also serves on the Educational Board of the Massachusetts Biotech Council, the Advisory Committee for the Center for Biomedical Engineering at Brown University, the Association for Laboratory Automation, the JALA Editorial Board, and the Strategy Committee of Children’s Hospital Boston. Prior to Quanterix, Kevin was President of PerkinElmer Life Sciences & Technology; CEO of Caliper Life Sciences; and CEO of Zymark Corporation. Earlier, he was President of FMC Pharmaceuticals and International Agricultural Products and held numerous management positions at DuPont. He is the 2013 Entrepreneur of the Year from Ohio State University and holds an Honorary Doctorate degree from Framingham State University for contributions in life sciences and personal medicine. Kevin holds a B.S. in Mechanical Engineering from Ohio State University and an M.B.A. from Ohio University.

Julie Khani, MPA, President, ACLA

Julie Khani became president of the American Clinical Laboratory Association (ACLA), the largest organization representing the public policy interests of laboratories, in 2017. Khani joined ACLA in July 2013 as senior vice president and was named executive vice president in 2016. Khani leads ACLA’s efforts to advance public policies that promote innovation and protect and enhance patient access to life-improving and life-saving diagnostics. ACLA members represent the diversity of the clinical laboratory industry and include national, regional, specialty, hospital, ESRD, anatomic pathology, skilled nursing facility and academic medical center laboratories. Ms. Khani is recognized as an effective leader, consensus builder, and advocate. Prior to joining ACLA, she served in senior roles at the National Association of Chain Drug Stores (NACDS). During her tenure at NACDS, she was instrumental in the inclusion of pharmacy access standards in Medicare Part D, establishing incentives for TRICARE beneficiaries to obtain immunizations at retail pharmacies, and played a leading role in the implementation of the Affordable Care Act provisions on Medicaid reimbursement for generic drugs. Previously, Khani served as legislative manager at Ford Motor Company, where she was responsible for health and labor issues and the company’s political action committee. Before joining Ford Motor Company, Ms. Khani was associate director, government relations at Planned Parenthood Pennsylvania Advocates, where she managed several successful statewide campaigns on health and welfare issues. She holds a bachelor of arts from New York University and a master of public administration from George Washington University.

J. Leonard Lichtenfeld, M.D., MACP, Deputy Chief Medical Officer, American Cancer Society, Inc.

Dr. J. Leonard Lichtenfeld currently serves as deputy chief medical officer for the American Cancer Society in the society’s Office of the Chief Medical Officer, Atlanta, GA. He joined the society in 2001 as a medical editor, and in 2002 assumed responsibility for managing the society’s newly created Cancer Control Science Department. In 2014, Dr. Lichtenfeld assumed his current role in the Office of the Chief Medical Officer where he provides extensive support to a number of Society activities. A frequent spokesperson in the media on behalf of the American Cancer Society, Dr. Lichtenfeld has also since 2005 written a widely read blog focused on topics related to cancer. He is board-certified in medical oncology and internal medicine, and practiced for more than 19 years. He has also been engaged in health care policy on a local, state, and national level for most of his professional career. Dr. Lichtenfeld is a graduate of the University of Pennsylvania and Hahnemann Medical College (now Drexel University College of Medicine) in Philadelphia and completed his postgraduate training at Temple University Hospital, Johns Hopkins University School of Medicine, and the National Cancer Institute. He is a member of Alpha Omega Alpha—the national honor medical society—and has received several awards including designation as a Master in the American College of Physicians in recognition of his professional accomplishments. Dr. Lichtenfeld currently resides with his wife and family in Thomasville and Atlanta, GA.

Neil Polwart, Ph.D., Novarum Founder, BBI Group Head of Mobile, Novarum DX

Neil Polwart is Novarum DX Founder and BBI Group Head of Mobile. With a PhD in Chemistry and around 15 years working in the diagnostics arena, Neil specializes in leading mHealth development, delivering connected health and true point of care technology solutions. Neil Polwart has worked in the field of bio-sensors, for nearly 20 years, developing and commercializing in-field tests for medical and environmental applications. His technical experience includes physics, chemistry, biotechnology and software, but in recent years, Neil has been increasingly focused on commercialization. In 2012, Neil led a joint venture - namely, Novarum DX based in Edinburgh, combining BBI’s diagnostics expertise with image capture software which transforms a smartphone into a mobile diagnostic reader. In late 2016, BBI Group completed the acquisition of Novarum DX, following successful commercialization of the technology with a number of key clients. Neil now heads up mobile within BBI Group, driving the ambitions of this global diagnostics business into the mHealth arena.

Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates

Bruce Quinn MD PhD is a leading expert on federal health policy and how innovative technology companies can adapt for success. In addition to his early career as a medical researcher, Dr. Quinn has 15 years of experience as a physician executive working for Accenture, the Medicare agency, and two elite Washington healthcare policy firms. As a strategy consultant, he helps companies build solutions to Medicare-related business challenges both at federal and local levels. Since 2008, over half of his experience has been devoted to the diagnostics and genomics industries.

Lea Carrington, MS, MBA, MT(ASCP), Director, Division of Immunology and Hematology Devices, FDA.

Lea Carrington is the Director of the Division of Immunology and Hematology Devices in FDA’s Office of In Vitro Diagnostic Device Evaluation and Radiological Health (OIR). DIHD assesses premarket performance data of a broad mix of assays and instruments including automated cell counters, flow cytometers, coagulometers and assays for allergy and immunology, thrombophilia, autoimmune diseases and neurological applications such as Alzheimer’s disease and traumatic brain injury. Before becoming the director of DIHD, she also served as Chief of the Hematology Branch. Before to joining the FDA, Lea worked as the Chief technologist in the Special Coagulation laboratory at Walter Reed Army Institute of Research where she performed a wide variety of automated and manual special coagulation tests and overseeing the laboratory’s initial CAP inspection and accreditation. Ms. Carrington is an ASCP certified Medical Technologist and holds an MBA from Johns Hopkins University and a M.S. in Biomedical Technology Development and Management from a partnership program at Georgetown University and Virginia Tech.

Mary Steele Williams, MNA, MT(ASCP)SM, CAE, Executive Director, Association for Molecular Pathology (AMP)

Mary is the Executive Director of the Association for Molecular Pathology (AMP), a medical professional society whose over 2,300 members work throughout the world in the diverse settings associated with molecular diagnostics research and clinical services: academic medical centers, community hospitals, commercial reference laboratories, government agencies, as well as product manufacturing, biotechnology and pharmaceutical companies. AMP expertise shapes public policy and clinical molecular testing through innovation, education, practice guidelines, and advocacy. Mary has been with AMP since 2004 and prior spent over a decade in the molecular diagnostics manufacturing industry.

Enabling Point-of-Care Diagnostics

Haim H. Bau, Ph.D., Professor, Mechanical Engineering and Applied Mechanics (MEAM), School of Engineering & Applied Science, University of Pennsylvania

Haim H. Bau is a professor of Mechanical Engineering and Applied Mechanics at the University of Pennsylvania. He received his Ph.D. from Cornell University (1980) and his undergraduate degree from the Technion Israeli Institute of Technology. His research focuses on micro and nano fluidics with applications to point-of-care diagnostics. He has published over 180 archival papers and numerous conference proceedings.’

Holger Becker, Ph.D., Founder & CSO, microfluidic ChipShop GmbH

Dr. Holger Becker is co-founder and CSO of microfluidic ChipShop GmbH. He obtained physics degrees from the University of Western Australia/Perth and the University of Heidelberg. He started to work on miniaturized systems for chemical analysis during his Ph.D. thesis at Heidelberg University, where he obtained his Ph.D. in 1995. Between 1995 and 1997 he was a Research Associate at Imperial College with Prof. Andreas Manz. In 1998, he joined Jenoptik Mikrotechnik GmbH. Since then, he founded and led several companies in the field of microsystem technologies in medicine and the life sciences. He was nominated for the German Founders Prize in 2004. He led the Industry Group of the German Physical Society between 2004 and 2009, was co-chair of MicroTAS 2013, and is the current chair of the SPIE ‘‘Microfluidics, BioMEMS and Medical Microsystems’’ conference. He serves on the Editorial Board of “Lab-on-a-Chip” as well as acting as a regular reviewer of project proposals on a national and international level.

Hong Cai, CEO, Mesa Biotech

Dr. Hong Cai is CEO and co-founder of Mesa Biotech. She has over 20 years of experience in molecular biology gaining her Ph.D. from USC. She invented the technology used in Mesa Biotech’s point-of-care molecular diagnostic platform. Prior to establishing Mesa Biotech, Dr. Cai spent 13 years as a principal investigator at Los Alamos National Laboratory, leading projects focused on the development of nucleic acid-based assays for forensics analysis, biothreat detection, and human disease diagnosis.

John C. Carrano, Ph.D., Chairman & CEO, Paratus Diagnostics, LLC

Dr. John C. Carrano is the Chairman and CEO of Paratus Diagnostics, a firm he founded that specializes in medical devices for point-of-care diagnostics. Dr. Carrano was previously Vice President, Research & Development at Luminex Corporation (NASDAQ: LMNX). Prior to Luminex, John was as a program manager at DARPA where he led several major Defense Department programs related to bio-sensing. Dr. Carrano was also on the faculty of the Department of Electrical Engineering and Computer Science at the United States Military Academy, and served as the Department Executive Officer. He retired from in the Army in 2005 with over 24 years of decorated service including a variety of command and staff positions worldwide. Dr. Carrano received his B.S. from West Point and his Ph.D. in Electrical Engineering from the University of Texas at Austin. He has several patents and over 60 publications and is a Fellow of SPIE. In 2012, he was appointed by Secretary Napolitano to the Department of Homeland Security Science Advisory Board.

William Clarke, Ph.D., MBA, DABCC, Associate Professor, Pathology, Johns Hopkins School of Medicine

Dr. Clarke received his Ph.D. in Analytical Chemistry from the University of Nebraska in 2000, followed by a post-doctoral fellowship in Clinical Chemistry at the Johns Hopkins School of Medicine. Following his post-doctoral fellowship, he remained at Johns Hopkins, where he is an Associate Professor, as well as the director of both POCT and Clinical Toxicology for the hospital. Dr. Clarke is author or co-author of over 100 peer-reviewed manuscripts or book chapters.

John Clarkson, Ph.D., CEO, Atlas Genetics

John’s background is in microbiology and molecular biology. He co-founded Molecular Sensing in 1999 and then joined US-based Osmetech when they acquired Molecular in 2004. John was founding CEO of Atlas Genetics and has led $90m in financing from blue-chip investors and strategics, including corporate funds of Novartis and J&J.

Steve Crouse, Chief Commercial Officer, Vortex Biosciences, Inc.

Steve Crouse is the Chief Commercial Officer, responsible for all commercial operations at Vortex Biosciences. Steve has 15 years of experience leading marketing and sales organizations in both large and small Life Science companies. Previously, Steve was the SVP of Sales and Marketing at Freeslate, Inc., leading global commercial operations.

Utkan Demirci, Ph.D., Associate Professor, Radiology, Canary Center for Cancer Early Detection, Stanford University School of Medicine

Dr. Utkan Demirci leads a productive group of ~30 researchers focusing on micro- and nano-scale technologies. He received his B.S. degree in Electrical Engineering in 1999 as a James B. Angell Scholar (summa cum laude) from University of Michigan, Ann Arbor. He received his M.S. degree in 2001 in Electrical Engineering, M.S. degree in Management Science and Engineering in 2005 and Ph.D. in Electrical Engineering in 2005, all from Stanford University. Dr. Demirci creates technologies to manipulate cells to enable solutions for real-world problems in medicine including applications in infectious disease and cancer diagnostics, cell encapsulation in nanoliter droplets for cryobiology, and bottom-up tissue engineering. His research interests involve applications of microfluidics, nanoscale technologies and acoustics in medicine, especially portable, inexpensive, disposable viral load technology platforms for HIV in resource-constrained settings for global health problems, 3-D bioprinting and tissue models including 3-D cancer and neural cultures. Dr. Demirci has published 117 peer-reviewed publications in journals including PNAS, Advanced Materials, Nature Communications, Small, Trends in Biotechnology, over 150 conference abstracts and proceedings, 10 book chapters, and four edited books. His work was highlighted in Wired Magazine, Nature Photonics, Nature Medicine, MIT Technology Review Magazine, Reuters Health News, Science Daily, and Science News. His scientific work has been recognized by numerous national and international awards including the NSF Faculty Early Career Development (CAREER) Award, and the IEEE-EMBS Early Career Achievement Award. He was selected as one of the world’s top 35 young innovators under the age of 35 (TR-35) by the MIT Technology Review. In 2004, he led a team that won the Stanford University Entrepreneur’s Challenge and Global Start-Up Competition in Singapore. His patents have been translated into multiple start-up companies including DxNOW, Koek Biotech and some of the technologies developed in his lab are clinically available across the globe.

Umut A. Gurkan, Ph.D., Assistant Professor, Case Biomanufacturing and Microfabrication Laboratory, Mechanical and Aerospace Engineering, Biomedical Engineering, Orthopaedics, Case Western Reserve University

Dr. Gurkan holds a Ph.D. degree in Biomedical Engineering from Purdue University. He completed his postdoctoral training in medicine at Brigham and Women’s Hospital, Harvard Medical School and Harvard-MIT Health Sciences and Technology after which he joined CWRU as Assistant Professor. Dr. Gurkan is leading the CASE Biomanufacturing and Microfabrication Laboratory (CASE-BML). CASE-BML’s mission is to improve human health and quality of life by a fundamental understanding of cell biomechanics, and through innovations in micro/nano-engineering, microfluidics, biosensors, and point-of-care systems. Dr. Gurkan has received national and international recognitions and awards for research and education, including, (1) NSF CAREER Award, (2) “Rising Star” Award from Biomedical Engineering Society (Cellular and Molecular Bioengineering and Advanced Biomanufacturing Divisions), (3) MIT Technology Review Innovator Under 35 Award (Turkey), (4) Case-Coulter Translational Research Partnership Award, (5) Clinical and Translational Science Collaborative Award, (6) Case School of Engineering Research Award, (7) Doris Duke Innovations in Clinical Research Award, (8) Belcher-Weir Family Pediatric Innovation Award, and (9) Glennan Fellowship from the University Center for Innovation in Teaching and Education. Dr. Gurkan has authored over 50 articles in peer-reviewed journals, numerous book chapters and patents.

Lea Carrington, Ph.D., Director, Division of Immunology and Hematology Devices, Office of In Vitro Diagnostic Device Evaluation and Radiological Health (OIR), Food and Drug Administration.

Erol Harvey, Ph.D., CEO, MiniFAB

Erol is the co-founder and CEO of MiniFAB. Erol has successfully combined a distinguished academic career and entrepreneurial spirit. With a Ph.D. in Plasma and Laser Physics from Monash University, he spent time in Oxford, UK before returning to Australia in 1999 to become Professor of Microtechnology at Swinburne University specialising in microfluidics, polymer microengineering and packaging. In 2002, together with Michael Wilkinson, he founded MiniFAB. Erol has served on a number of local and federal Australian government committees, international program review panels and in 2006 Erol was elected a Fellow of the Australian Academy of Technological Sciences and Engineering (ATSE).

Marilynn A. Larson, M.Sc., Ph.D., Assistant Professor, NSRI Chem/Bio Countermeasures Research Coordinator, Pathology and Microbiology, University of Nebraska Medical Center

Marilynn Larson, M.Sc., Ph.D. is an Assistant Professor and Principal Investigator in the Department of Pathology and Microbiology at the University of Nebraska Medical Center (UNMC) in Omaha. She is the Research Coordinator for Chemical/Biological Detection and Countermeasures for the National Strategic Research Institute (NSRI) / University of Nebraska that includes UNMC, the University of Nebraska-Lincoln, the University of Nebraska at Omaha, and the University of Nebraska at Kearney. Dr. Larson has substantial expertise in molecular microbiology, and her research interests include the development of diagnostics and therapeutics for pathogen identification and treatment, respectively, as well as determining the molecular mechanisms that allow pathogens to replicate and persist. She is certified by the Centers for Disease Control and Prevention (CDC) Select Agent Program to work with BSL-3 select agents and has been directly involved in the development of accurate pathogen detection assays supported by the United States Department of Defense.

Donald G. Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center

Donald G. Klepser, Ph.D., MBA, is associate professor and vice chair of pharmacy practice at the University of Nebraska Medical Center, College of Pharmacy. He has a Ph.D. in Pharmaceutical Socioeconomics from the University of Iowa, an MBA from the University of Minnesota’s Carlson School of Management, and a Bachelor’s degree in Communications from the University of Michigan. He has studied the use of POC testing in community pharmacies for the past 9 years and is currently the primary investigator on grants to develop community pharmacy practice models for managing diseases such as HIV, HCV, influenza, and group A Streptococcus. He is also the primary investigator on grants to better understand how state and local health departments perceive the role of pharmacists conducting POC tests.

Andrew H. Ko, M.D., Professor, Clinical Medicine, Division of Hematology/Oncology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco

Dr. Andrew Ko did his undergraduate studies at Brown University in Providence, Rhode Island, graduating with honors in Applied Mathematics and Biology, and then received his medical degree at the Johns Hopkins School of Medicine. He went on to complete residency training in Internal Medicine at Beth Israel Hospital/Harvard Medical School, and a fellowship in Medical Oncology at Stanford University Medical Center. He is currently a Professor of Clinical Medicine in the Division of Hematology/Oncology at the University of California, San Francisco. His primary clinical and research interests focus on gastrointestinal malignancies, an arena in which he has co-authored more than 100 peer-reviewed articles, abstracts, and book chapters. He has led and been involved in the development and evaluation of new therapeutic agents ranging from novel cytotoxics to molecular targeted agents to immunotherapies, with a particular emphasis on evaluating these in patients with pancreatic cancer. He has been interested in identifying individual patient/tumor characteristics that influence prognosis and response to specific therapies, including both tissue- and blood-based biomarkers. Dr. Ko has served on the scientific program and grants review committees for the American Society of Clinical Oncology (ASCO); is a participating member of the National Cancer Institute’s Pancreatic Cancer Task Force and the National Comprehensive Cancer Network (NCCN) Pancreatic Cancer guidelines committee; and is an Associate Editor for the Journal of Clinical Oncology. Within UCSF, he heads the GI site committee, where he works closely with colleagues in the development and oversight of trials focused on pancreatic, colorectal, hepatobiliary, esophagogastric, and neuroendocrine malignancies; and also chairs the Cancer Center scientific Protocol Review Committee. He has been married for 12 years to his wife, Christine, a civil engineer. They have two children, Naomi (10) and Elliott (6).

Colleen S. Kraft, M.D., Associate Professor, Pathology & Laboratory Medicine, Emory University School of Medicine

Colleen Kraft’s interests are in translational research of genomic sequencing to clinical care. She has experience in the genomics-based analysis of HIV-1, human rhinovirus, Staphylococcus aureus and the microbiota related to fecal transplantation. She started the fecal transplant program at Emory University and am involved in clinical trials.

Kevin Little Ph.D., CSAP. Chief Scientific Officer, 3D Signatures Inc.

Kevin Little joined 3D Signatures in April 2017 to lead its scientific and clinical development programs. He has spent a career promoting the impact of collaborative research ecosystems. Dr. Little previously led the establishment of the PERFORM Centre, a health research and community services complex in Montreal, as its Founding Chief Administrative Officer. Prior to that, Dr. Little led the New Zealand government’s economic development work building strategic investment relationships across the biotechnology sector. He completed postdoctoral research in clinical gene therapy at the University of Auckland, and holds a PhD in Experimental Medicine from McGill University, and a B.Sc. in Biology from the University of Victoria. Kevin is a Certified Strategic Alliance Professional.

Barbara McIntosh, Vice President, Business Development, Scienion

Barbara has joined Scienion to expand business development efforts. She is based in Southern California. Prior to joining Scienion, she did Sales and Marketing at BioDot for 12 years.

Chris Myatt, CEO, MBio Diagnostics, Inc.

Chris Myatt is the Founder and CEO of MBio. Prior to MBio, Chris founded and grew Precision Photonics Corporation, a laser technology company that is now a part of IDEX. Chris was trained as an atomic physicist at the University of Colorado.

James H. Nichols, Ph.D., DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine

James H. Nichols, Ph.D., DABCC, FACB is a Professor of Pathology, Microbiology, and Immunology, Medical Director of Clinical Chemistry and Point-of-Care Testing at Vanderbilt University School of Medicine. Dr. Nichols received his B.A. in General Biology/Premedicine from Revelle College, University of California at San Diego. He went on to complete a Masters and Doctorate in Biochemistry from the University of Illinois, Urbana-Champaign. Jim was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, MN. He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions. Jim later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, MA and was a Professor of Pathology at Tufts University School of Medicine. Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing and toxicology.

M. Allen Northrup, Ph.D., FRSC, CEO, MIODx

M. Allen Northrup, Ph.D., FRSC has over 30 years of diagnostics instrumentation development both as an inventor and entrepreneur. He was a Co-Founder, CTO and Vice President of Cepheid, and the Founder of Microfluidic Systems. Currently, he is Co-Founder (2014) and CEO of MIODx, working on advances in diagnostics for cancer and infectious diseases. Dr. Northrup several engineering and entrepreneurial business awards. Dr. Northrup is on the Science Advisory Board of Fluigent (Paris) and Pharmafluidics (Gent, Belgium), a Member of the National Academy of Engineering (NAE.edu), a Fellow and Chairman of the Industry Council of the American Institute of Medical and Biological Engineers (AIMBE.org), and a Fellow of the Royal Society of Chemistry (RSC.org).

Cece O'Connor, Global Director, UX Strategy & Design, Invetech

Prior to joining Invetech, Ms. O’Connor was managing director of Panorama Innovation, an innovation and design consultancy. She also led innovation, transformation and concept design roles for Callaway Golf and Gillette. Ms. O’Connor has a bachelor’s degree from the University of San Diego and studied design communication at the Art Center College of Design. She graduated from the Executive Program at UCLA Anderson and has lectured on Design Research and Organizational Modeling at Northwestern University and IIT Institute of Design - Chicago.

Brendan O'Farrell, Ph.D., President, DCN Diagnostics

Brendan has worked in the rapid diagnostics field for over 20 years in various R&D, Manufacturing and Management capacities. Having gained a Ph.D. in Medical Microbiology from University College Dublin, he began his commercial career in the rapid diagnostics business at Trinity Biotech in Dublin as a development team leader. After immigrating to the US, he became Director of R&D, and later, the Director of Manufacturing at Saliva Diagnostic Systems in Vancouver, WA. Here, he was responsible for the development and manufacturing of a wide range of FDA-regulated medical diagnostic products. Upon moving to California, Brendan became Vice President of Technology Development at BioDot Inc. At BioDot, he was responsible for the engineering and process development groups. He also established The One Step…One Solution (OSOS) Program, which was a successful assay development and consulting division of BioDot’s business. In 2005, Brendan and DCN co-founder, Michael Surmanian, effected a management buyout of the OSOS business and transitioned it into DCN.

Richard Spero, Ph.D., CEO, Redbud Labs

Richard Spero is co-founder, CEO, and systems engineering lead at Redbud Labs. He is a co-inventor of Redbud Posts, a biomimetic cilia technology used for microscale pumping, mixing, cell sorting, and analyte isolation. Prior to founding Redbud Labs, Dr. Spero earned his PhD in Physics at the University of North Carolina at Chapel Hill, where he studied blood clot rheology and developed novel systems for magnetic manipulation and time-dependent high content screening.

Eric van Gieson, Ph.D., Professor, University of Nebraska Medical Center

No bio available.

Clinical NGS Assays: Technologies and Validation

Andrew Barry, Product Marketing Manager, Target Enrichment, New England Biolabs, Inc.

Andrew Barry is the Product Marketing Manager for Target Enrichment at New England Biolabs. He has experience supporting high-throughput genomic research both in academic and industrial settings. While at the Broad Institute, Andrew managed an automation and process development team within the Genomics Platform responsible for early development sample preparation processes for next generation sequencing. Later, at Caliper Life Sciences and PerkinElmer, he directed an R&D team responsible for global deployment of automation and microfluidic solutions to support preparation and analysis of biologic samples for next generation sequencing and analytical protein purification. Andrew later returned to the Broad Institute to launch the Genomic Services initiative that provides global researchers access to Broad's sequencing capacity. Andrew holds a Bachelor of Science degree in Biology and a Master of Science degree in Biomedical Engineering.

Eric Duncavage, M.D., Assistant Professor, Pathology and Immunology, Division of Anatomic and Molecular Pathology, Washington University School of Medicine in St. Louis

Dr. Duncavage is the director of hematopathology at Washington University in St. Louis. He is board-certified in anatomic pathology, clinical pathology, molecular pathology, and hematopathology and is active in both clinical service and translational research. Dr. Duncavage along with others in the department of Pathology and Immunology was instrumental in establishing the first next generation sequencing-based oncology diagnostics laboratory at an academic medical center in 2011. He has authored numerous manuscripts detailing clinical sequencing methods and is a world-recognized leader in field of sequencing-based diagnostics. In addition Dr. Duncavage serves as the medical director of Cofactor Genomics, a leader in clinical RNA sequencing. Dr. Duncavage’s grant-funded research is focused on understanding the clonal evolution and progression of myelodysplastic syndromes including the application of molecular-based measurable residual disease (MRD) monitoring to determine treatment response.

Helen Fernandes, Ph.D., Associate Professor, Personalized Genomic Medicine, Pathology and Cell Biology, Columbia University Medical Center

Helen Fernandes PhD, is an Associate Professor of Pathology in the Department of Pathology and Cell Biology and the Co-director of Genomic Oncology in the Personalized Genomic Medicine Laboratory, at Columbia University Medical Center. She has over 20 years of experience in Molecular Pathology and has implemented clinical next generation sequencing assay for the detection of somatic variants in cancer. Dr. Fernandes is involved in the training and education of molecular diagnosticians and has presented at several meetings and webinars nationally and internationally. She is an active member of the Association for Molecular Pathology (AMP), the American Association for Clinical Chemistry (AACC).

Larissa V. Furtado, M.D., Medical Director, Molecular Oncology, ARUP Laboratories; Assistant Professor, Pathology University of Utah

Dr. Furtado is a molecular oncology medical director at ARUP Laboratories and an assistant professor of pathology at the University of Utah School of Medicine. She completed her residency in anatomic and clinical pathology at the University of Utah and ARUP Laboratories, where she was chief resident, and her molecular genetic pathology fellowship at the University of Michigan. Prior to joining ARUP as a medical director, Dr. Furtado worked as an assistant professor of pathology at the University of Chicago and was co-director of the University of Chicago Clinical Genomics and Molecular Diagnostics Laboratories. Dr. Furtado’s research interests include genomic diagnostics in solid tumors and molecular diagnostic methods in oncology.

Susan J. Hsiao, M.D., Ph.D., Assistant Professor, Pathology and Cell Biology, Columbia University Medical Center

Susan Hsiao is Assistant Professor of Pathology and Cell Biology at Columbia University Medical Center and Assistant Director in the Laboratory of Personalized Genomic Medicine. She received her MD/PhD from New York University School of Medicine and trained in anatomic pathology and molecular genetic pathology at Columbia University Medical Center and University of Pittsburgh Medical Center.

Mirna Jarosz, Director, NGS Scientific Applications, Integrated DNA Technologies

Dr Mirna Jarosz joined IDT in 2015, as Director of NGS Scientific Applications. She completed her PhD in chemistry at MIT in 2004, and started at Helicos BioSciences, where she helped develop the world’s first commercial single-molecule DNA sequencer. In 2010, she joined Foundation Medicine Inc., and led a team developing library preparation and targeted sequencing technologies. In 2012 Dr Jarosz went to 10X Genomics, where she led biochemistry efforts, and developed applications for their linked-read technology.

Eric Konnick, M.D., MS, Acting Assistant Professor, Laboratory Medicine, University of Washington

Prior to enrolling in medical school, Dr. Konnick was a research and development scientist at ARUP laboratories for 7 years where he developed and validated laboratory tests and informatics tools for the molecular infectious disease laboratories. After completing medical school at the University of Utah, he completed an anatomic and clinical pathology residency and molecular genetic pathology fellowship at the University of Washington. He is currently an acting assistant professor in the genetics and solid tumors laboratory (GSTL) in the department of laboratory medicine at the University of Washington. Dr. Konnick is responsible for specimen acquisition & qualification, assay development, and signout of NGS oncology-related assays in the GSTL. His research interests involve the overlap of somatic and germline mutations, and how NGS approaches can benefit the care of patients and their families. He is actively involved in the Association for Molecular Pathology and the College of American Pathologists at the national level.

Nina Korzeniewski, Ph.D., Business Development Manager, Menarini Silicon Biosystems

Nina Korzeniewski received her Ph.D. in Molecular Virology and Microbiology from the University of Pittsburgh School of Medicine followed by postdoctoral training at the University of Heidelberg School of Medicine, focused on prostate and kidney cancer translational research. Nina spent a year being the expert consultant for DEPArray project design at the NIH and has broad competence on usage of the DEPArray for resolving tumor heterogeneity and isolating CTCs.

Yong-Jie Lu, MD, Ph.D., Reader Medical Oncology, Centre for Molecular Oncology, Barts Cancer Institute

Dr. Yong-Jie Lu is a Reader in Medical Oncology at Barts Cancer Institute. He has completed his MD in 1992 and PhD (at Cancer Institute/Hospital, CAMS) in 1995. His research is currently focusing on biomarker development and ‘liquid biopsy’, in particular in the area of circulating tumour cells.

Jason Merker, M.D., Ph.D., Assistant Professor, Pathology; Co-Director, Stanford Medicine Clinical Genomics Service, Stanford University School of Medicine

Dr. Merker is an Assistant Professor of Pathology and Co-Director of the Stanford Medicine Clinical Genomics Service, a joint effort between Stanford Children’s Health, Stanford Health Care, and the Stanford University School of Medicine. The Clinical Genomics Service is clinical and laboratory service that uses genome and exome sequencing as well as other advanced molecular testing to assist in the diagnosis of genetic disease. Dr. Merker received his M.D. and Ph.D. in Genetics from the University of North Carolina at Chapel Hill. He then completed residency training in Clinical Pathology and fellowship training in Molecular Genetic Pathology and Clinical Cytogenetics at Stanford Hospital and Clinics, followed post-doctoral training in cancer genomics at Stanford University. Dr. Merker also directs an active research group that focuses on two areas: 1) development of improved experimental and computational approaches related to the use of genomic sequencing and other “omics” assays for clinical care, and 2) identification and characterization of acquired and heritable genetic variants that are important for the development of hematologic disorders and other malignancies.

John D. Pfeifer, M.D., Ph.D., Vice Chair for Clinical Affairs, Pathology, Washington University School of Medicine

Dr. Pfeifer is Vice Chair for Clinical Affairs in the Department of Pathology at Washington University School of Medicine. He is a Professor of Pathology, and is board certified in Anatomic Pathology and also Molecular Genetic Pathology. Over the last several years, he has helped lead the development of Genomics and Pathology Services at Washington University in St. Louis (GPS@WUSTL), a CAP/CLIA certified lab designed around next generation sequencing (NGS) to support patient care, clinical trials, and research. Dr. Pfeifer manages not only the development of the wet bench analytics, bioinformatics, and faculty staffing models required to support clinical NGS, but also test design (including gene-panel based testing versus exome- or genome-based sequencing) for inherited diseases and cancer.

Dr. Pfeifer's academic interests are focused on investigation of the role of molecular genetic testing in the analysis of tissue specimens, specifically on the methods and clinical settings in which molecular testing provides independent information that increases diagnostic accuracy or can be used to guide therapy to improve patient outcomes. Dr. Pfeifer is also chairman of the CAP scientific technical working group involved with the SPOT/Dx Diagnostic Quality Assurance Pilot Study.

Benjamin Pinsky, M.D., Ph.D., Assistant Professor, Departments of Pathology and Medicine, Stanford University School of Medicine; Medical Director, Clinical Virology Laboratory, Stanford Health Care and Stanford Children’s Health

Benjamin Pinsky, M.D., Ph.D., Stanford University School of Medicine, finished undergraduate biochemistry at Harvard University before entering the Medical Scientist Training Program at the University of Washington. Under the mentorship of Sue Biggins at Fred Hutchinson Cancer Research Center, he earned his Ph.D. investigating the basic mechanisms of chromosome segregation using Saccharomyces cerevisiae as a model organism. He did his clinical pathology residency at Stanford, working with mentors Niaz Banaei and Baron, publishing several studies in infectious disease diagnostics. He provided key laboratory expertise and leadership during the 2009 influenza pandemic.

Pinsky, an Assistant Professor, currently serves as Medical Director of the Clinical Virology Laboratory for Stanford Hospital & Clinics and the Lucile Packard Children's Hospital. His research interests include the design of novel diagnostics and investigation of the clinical relevance of viral molecular testing, particularly in transplant virology and tropical medicine, where he studies a number of viral pathogens, including CMV and dengue virus.

Todd A. Ritter, Vice President, Federal Solutions, Orion Health

Todd joined Orion Health in 2017 and holds the role of Vice President of Federal Solutions. He is responsible for business growth and program execution across the large government programs with a primary focus on the Veteran’s Administration and Department of Defense. Key areas of focus include customer engagement, program development and partnership strategy, and growing our leadership and delivery capability across this important market sector. Todd has 25+ years’ experience in leadership, focused on system development and integration of diagnostics with healthcare IT and surveillance systems.

Robert Schlaberg, M.D., MPH, Medical Director, ARUP Laboratories, Assistant Professor of Pathology, The University of Utah

Robert Schlaberg, M.D., Dr. med., MPH is a medical director at ARUP Laboratories, an Assistant Professor of Pathology at the University of Utah, and Co-founder and CMO at IDbyDNA, Inc. He completed his Clinical Pathology residency and Master of Public Health training at Columbia University, and a Medical Microbiology fellowship at ARUP Laboratories. His research is focused on next-generation sequencing-based infectious disease diagnostics and is supported in part by the Bill & Melinda Gates Foundation. He has co-developed Taxonomer, an ultrafast, user-friendly, web-based metagenomics data analysis tool with the goal of bringing precision medicine to infectious disease diagnosis. He is board-certified in Clinical Pathology and Medical Microbiology by the American Board of Pathology. He is a member of the College of American Pathologists’ Microbiology Resource Committee and Standard Committee.

Patricia Simner, Ph.D., D(ABMM), Director, Bacteriology and Parasitology, Division of Medical Microbiology, John's Hopkins

Dr. Trish Simner is an Assistant Professor in the Department of Pathology at the Johns Hopkins University and is the Director of the Medical Bacteriology and Parasitology Laboratories for the Johns Hopkins Medical Institutions.

Joshua T. Smith, Ph.D., Research Staff Member, Translational Systems Biology and Nanobiotechnology, IBM T.J. Watson Research Center

Joshua Smith received his Ph.D. in Electrical Engineering from Purdue University in 2011 on a National Science Foundation Graduate Research Fellowship Award and joined the IBM T. J. Watson Research Center as a Research Staff Member. While he is most widely known for his work on low-dimensional nanoelectronics, Dr. Smith developed a growing interest in biomedical engineering and biotechnology, and in 2013 he helped establish the Translational Systems Biology and Nanobiotechnology Group at IBM Research. Within the group, he oversees R & D efforts as the technical team lead and works to establish paths toward manufacturing for microfluidic devices aimed at separation and detection of single molecules for advanced biomedical diagnostics and preparative platform technologies. His current research interests include the translation and commercialization of diagnostics tools for healthcare. Dr. Smith holds an Adjunct Assistant Professor position at Columbia University in the Department of Electrical Engineering and is an IBM Master Inventor with over 60 patents.

Harriet Wikman, Ph.D., Professor, Institute of Tumor Biology, University Medical Center Hamburg-Eppendorf

Dr. Harriet Wikman is a Group Leader and Professor of Tumor Biology at the University Hospital Hamburg-Eppendorf. Harriet’s main research interest is to understand the biology behind the different steps of the metastatic cascade, particularly the genetic factors leading to early tumor cell dissemination, and pathways important for site-specific metastasis of various epithelial tumors. Harriet has won numerous awards and has authored over 50 publications, numerous book chapters, review articles, and holds several patents.

Liz Worthey, Ph.D., Faculty Investigator, Director, Software Development and Informatics, HudsonAlpha Institute for Biotechnology

Dr. Liz Worthey has degrees in Immunology, Genomics, and Genetics and has studied at leading Universities including Glasgow, Birmingham, Oxford, and Stanford Universities, Imperial College London, and the University of Washington. She has more than 20 years of experience in the development and application of tools, methods, and algorithms to extract knowledge from large genomics and other research and clinical datasets. Dr. Worthey performed the first analyses that successfully used genomic data to change medical treatment and together with colleagues built the first Genomic Medicine program in the world. She has been invited to give talks around the world on this topic. At HudsonAlpha she is the head of the Software Development and Informatics (SDI) Group.

Her group has three distinct missions: 1) to support the Institutional Informatics needs within HudsonAlpha by developing software for analysis of genomics datasets and through application of these tools to turn big data into generalizable research knowledge, 2) to support the Clinical Informatics needs of the various HudsonAlpha clinical entities to turn genomic data into knowledge with clinical utility, and 3) to undertake novel research into the genetic underpinnings of rare and more common disease including cancer in order to provide research findings and clinically useful data for human diseases.

Circulating Tumor Cells

Andrew J. Armstrong, M.D., Associate Professor of Medicine; Co-Director, GU Oncology Research Program, Medicine and Surgery, Duke Cancer Institute

Dr. Armstrong is Associate Professor of Medicine, Surgery, Pharmacology and Cancer Biology and Associate Director of the Duke Cancer Institute Genitourinary Clinical Research Program. He is a medical oncologist and internationally recognized expert in experimental therapeutics and biomarker development in genitourinary cancers, particularly in prostate cancer. He trained at Duke as a biomedical engineer, received his medical degree at the University of Virginia, medicine residency training at the Universtity of Pennsylvania, fellowship and public health clinical investigation training at Johns Hopkins and the Bloomberg School of Public Health, and joined Duke’s faculty in 2006.

As a clinical and translational investigator, he is focused on experimental therapeutics for patients with advanced genitourinary malignancies, particularly with a focus on prostate cancer and the investigation of biomarkers of response and benefit. He is funded by the US Department of Defense, the Prostate Cancer Foundation and Movember, the NIH, and the American Cancer Society for his work on circulating tumor cell biology and epithelial plasticity. He co-chaired Prostate Cancer Working Group 3 which established guidelines in 2016 for clinical research in advanced prostate cancer, and is a leading member of the NCCN Prostate Cancer panel for national clinical guidelines on the treatment of men with prostate cancer. He has developed a number of experimental agents in prostate and renal cell cancer, including completed or ongoing trials of mTOR inhibitors and PI3 kinase inhibitors, immunomodulatory agents, hormonal therapies such as enzalutamide, and anti-angiogenic agents, and is heavily involved in the leadership of multiple ongoing phase 1-4 treatment and biomarker trials in men with advanced prostate cancer. He has authored over 120 peer reviewed publications as well as numerous chapters, reviews, and abstracts.

Leonora Balaj, Ph.D., Instructor, Neurology, Massachusetts General Hospital, Harvard Medical School

Leonora Balaj is Instructor in Neurology at Massachusetts General Hospital and Harvard Medical School. She received her B.S. in Biology from the University of Bridgeport in CT and her PhD in Medicine from the VU University Amsterdam, The Netherlands. During her graduate studies, she worked in the laboratory of Dr. Breakefield at the Massachusetts General Hospital in the department of Neurology. Her work focuses on the characterization of brain tumor derived vesicles as a tool for cell-cell communication as well as a source for biomarkers.

Mark C. Connelly, Ph.D., Chief Industrial Operations and R&D Officer, U.S. Menarini Silicon Biosystems, Inc.

Mark C. Connelly, Ph.D., is Scientific Director Cellular Research, and Site Director for Janssen Diagnostic’s Huntingdon Valley facility. He has been leading research and development in the field of rare cell detection and analysis for over 15 years. Dr. Connelly previously served as Vice President of Reagent Development for Immunicon Corporation. Over the last 30 years, Dr. Connelly has lead the development and commercialization of numerous IVD and RUO products and services in the fields of Clinical Chemistry, Retrovirology, Flow Cytometry, Blood Banking, Autoimmunity, Cancer Diagnostics, and Pharmaceutical Drug Development. Dr. Connelly received his B.S. in Biology from Syracuse University, and his Ph.D. in Immunochemistry from the University of Rochester.

Daniel Danila, M.D., Genitourinary Oncology Service, Medicine, Memorial Sloan-Kettering Cancer Center

Dr. Daniel Danila graduated in 1996 from C Davila University of Medicine in Bucharest, Romania. Attracted by the promise of targeted therapy to increase treatment efficacy and limit toxicity, he pursued a career in translational research, initially working on pituitary tumorigenesis at the Massachusetts General Hospital in Boston, MA.

After he joined Memorial Sloan Kettering Cancer Center in 2005, he focused on the critical unmet needs in prostate cancer clinical research and management, specifically in understanding prognosis, determining whether therapies are effective, and profiling disease to guide treatment selection using blood based diagnostics. He is an author of numerous studies in these areas, including in PNAS, JCO, Lancet, NEJM, Clin Cancer Research, and he is a member on the Editorial Boards of several journals. He received awards from ASCO, AACR, and the Department of Defense to study the role of molecularly profiling circulating tumor cells as biomarkers in patients with prostate cancer.

Utkan Demirci, Ph.D., Professor, Radiology, Stanford University

Dr. Demirci is currently a Professor at Stanford University School of Medicine with tenure at the Canary Center for Early Cancer Detection. Prior to his Stanford appointment, he was an Associate Professor of Medicine at Brigham and Women's Hospital, Harvard Medical School and at Harvard-MIT Division of Health Sciences and Technology serving at the Division of Biomedical Engineering, Division of Infectious Diseases and Renal Division. He leads a group of 20+ researchers focusing on micro- and nano-scale technologies. He received his B.S. degree in Electrical Engineering in 1999 as a James B. Angell Scholar (summa cum laude) from University of Michigan, Ann Arbor. He received his M.S. degree in 2001 in Electrical Engineering, M.S. degree in Management Science and Engineering in 2005, and Ph.D. in Electrical Engineering in 2005, all from Stanford University.

Terence Friedlander, M.D., Assistant Clinical Professor, Hematology/Oncology, University of California San Francisco Medical Center

Dr. Friedlander specializes in genitourinary cancer particularly cancer of the bladder and prostate. His research interests focus on understanding the basic biology of these diseases and in developing new ways to overcome treatment resistance. He earned a medical degree at New York University Medical School and completed a residency in internal medicine at UCSF. He received a Fulbright Scholarship in 2006 to study medical ethics, completed a fellowship in medical oncology at UCSF, and has been on faculty there since 2010. He has received career development grants from the US Department of Defense and the Prostate Cancer Foundation.

His recent research explores the prognostic and predictive value of circulating tumor cells (CTCs) in GU malignancies. As a clinical academic oncologist, he serves as principal investigator or co-investigator on a number clinical trials in advanced prostate and bladder cancer, including studies of novel immune therapies, and additionally is a leader of the UCSF Cancer Immunotherapeutics Program. This work spans from the bench to the bedside, and he hopes it will help us to be able to predict which are likely to respond to anticancer therapies and allow us to tailor our clinical strategy to avoid giving toxic and ineffective therapies, and to select patients most likely to benefit.

James Hicks, Ph.D., Professor, Biological Sciences, University of Southern California

James Hicks is Professor and Member of the Bridge Institute and the Michaelson Center for Convergent Science at the University of Southern California. He is recognized for his innovative work in yeast genetics and single cell cancer genomics. He has co-founded multiple companies in the fields of biotechnology and health information. His current work is aimed at applying single cell biology to clinical problems, focusing on breast and prostate cancer.

Shana Kelley, Ph.D., Professor, Biochemistry, University of Toronto

Dr. Shana Kelley is a Distinguished Professor of Biochemistry, Pharmaceutical Sciences, Chemistry, and Biomedical Engineering at the University of Toronto. Dr. Kelley received her Ph.D. from the California Institute of Technology and was a NIH postdoctoral fellow at the Scripps Research Institute. Her research interests are the development of new technologies for clinical diagnostics and drug delivery. Dr. Kelley’s work has been recognized with a variety of distinctions, including being named one of ‘Canada’s Top 40 under 40′, a NSERC E.W.R. Steacie Fellow, and the 2011 Steacie Prize. She has also been recognized with the Pittsburgh Conference Achievement Award, an Alfred P. Sloan Research Fellowship, a Camille Dreyfus Teacher-Scholar award, a NSF CAREER Award, a Dreyfus New Faculty Award, and was also named a “Top 100 Innovator” by MIT’s Technology Review. She is a founder of two molecular diagnostics companies, GeneOhm Sciences (acquired by Becton Dickinson in 2005) and Xagenic Inc.

James Hicks, Ph.D., Professor, Biological Sciences, University of Southern California James Hicks is Professor and Member of the Bridge Institute and the Michaelson Center for Convergent Science at the University of Southern California. He is recognized for his innovative work in yeast genetics and single cell cancer genomics. He has co-founded multiple companies in the fields of biotechnology and health information. His current work is aimed at applying single cell biology to clinical problems, focusing on breast and prostate cancer.

Dario Marchetti, Ph.D., Director, Center of the Biomarker Research Program, The Methodist Hospital Research Institute

Dr. Marchetti is an international recognized expert and authority in the field of CTCs as clinically useful tools to combat cancer metastasis for improved patient outcome. With keen insights into the biology of brain metastasis, he pioneered models for discoveries of molecular determinants underlying brain metastasis and biomarker properties of brain-homing CTCs. As a consummate scientist, Dr. Marchetti’s bibliography include 179 publications of which 79 are in peer-reviewed journals in the fields of neuroscience and oncology. He has received numerous awards and secured uninterrupted funding for 25 years by receiving grants from federal, state, institutional and private Agencies.

Stuart Martin, Ph.D., Professor, Physiology, Greenebaum NCI Comprehensive Cancer Center, University of Maryland School of Medicine

Dr. Martin received his Ph.D. from the University of California, San Diego, after training as a Howard Hughes undergraduate research fellow at the University of Virginia. Dr. Martin completed a Damon Runyon postdoctoral fellowship at Harvard Medical School that combined functional genomic studies with mouse models of breast tumor metastasis, under the mentorship of Dr. Phil Leder. In 2004, Dr. Martin joined the Greenebaum Cancer Center at the University of Maryland School of Medicine. Dr. Martin is working to apply physical science and engineering approaches to the study of cancer metastasis. In 2010, Dr. Martin was one of only 3 investigators nationwide recognized with an Era of Hope Scholar Award from the Congressionally-directed Medical Research Program for his innovative research on breast cancer metastasis.

Hsian-Rong Tseng, Ph.D., Professor, Molecular and Medical Pharmacology, University of California Los Angeles

To facilitate the commercial transition of the NanoVelcro Assays, Dr. Tseng founded CytoLumina Technologies Corp., a biotechnology company that has licensed intellectual properties associated with NanoVelcro Assays from UCLA. The company is on a mission to make dramatic improvements in cancer patient quality of life through its patented high sensitivity liquid biopsy nanotechnology for cancer detection and monitoring. CytoLumina’s CTC enumeration assay is currently undergoing an FDA 510(k) medical device clearance for prognostic utility in prostate cancer. In December 2016, CytoLumina was officially invited to participate in White House Cancer Moonshot’s Blood Profiling Atlas in pursuit of accelerating blood profiling diagnostic technologies for the benefit of patient quality of life.

Yazhen Zhu, M.D., Ph.D., Project Scientist, Pharmacology, University of California Los Angeles; Medical Director, CytoLumina

Dr. Yazhen Zhu is a Pathologist who obtained her PhD training in the fields of both Pathology and Oncology from Fudan University. She is currently an Assistant Researcher in the Department of Molecular & Medical Pharmacology in David Geffen School of Medicine at UCLA, responsible for exploring new clinical applications of NanoVelcro CTC Assays. She also serves as Medical Director in CytoLumina Technologies Corp, overseeing the clinical studies and regulatory clearance of the company’s NanoVelcro CTC Assays. Over her stay in Guangdong provincial hospital of TCM as an attending physician in 2010-2017, Dr. Zhu has accumulated extensive experience in managing clinical laboratory for cancer molecular diagnosis and conducting translation research on testing new cancer diagnostic assays. Her interest remains in bridging the gap between translational medicine and unmet clinical needs in the field of molecular pathology and oncology.

Biomarkers for Cancer Immunotherapy and Combinations

Robert A. Anders, M.D., Ph.D., Associate Professor of Pathology, Division of GI and Liver Pathology, Bloomberg~Kimmel Institute for Cancer Immune Therapy Johns Hopkins Medicine

Dr. Robert A. Anders is an Associate Professor of Pathology at the Johns Hopkins School of Medicine in the Division of Gastrointestinal and Liver Pathology at Johns Hopkins Hospital. He also serves as co-director of the Tumor Microenvironment Laboratory in the Bloomberg~Kimmel Institute for Immune Cancer Therapy. Dr. Anders completed medical and post-graduate training at Mayo Medical School in Rochester, Minnesota, where he received his M.D. and Ph.D. degrees in 1998. He then studied anatomic and clinical pathology residency training followed by Gastrointestinal and Liver pathology clinical fellowships as well as a postdoctoral research fellowship in Immunology at the University of Chicago. His research interests focus on tumor immunology and specifically interrogating the immune microenvironment in tumor tissue.

Meredith Berry, Ph.D., Director, Laboratory Operations and Pharma Services, Laboratory Operations and Pharma Services, NeoGenomics

No Bio Available

Alan L. Epstein M.D., Ph.D., Professor, University of Southern California Keck School of Medicine

Alan Epstein received his bachelor’s degree from Wesleyan University and his MD/PhD degrees from Stanford University School of Medicine. His research focuses on various aspects of tumor biology but most recently, on the development of reagents for the immunotherapy of cancer. In addition, his laboratory is involved in elucidating the host/tumor interaction including the induction and function of suppressor cell populations and methods to reverse their activity in cancer. Over a 34 year career, he has developed several antibodies for the treatment of cancer including Lym-1 for lymphoma therapy and Tumor Necrosis Antibodies that target necrosis in cancer lesions. In addition, he has generated a number of diagnostic antibodies including a human myeloid derived suppressor cell clinical assay for the diagnosis and monitoring of cancer patients. His latest research interests are in the area of genetically engineered T cells for the treatment of solid tumors in patients. He has founded three biotechnology companies, has acted as a consultant to the industry in his field of expertise, and has one commercially FDA approved antibody product in China. Dr. Epstein has over 165 peer reviewed publications and 25 patents on reagents and methods for cancer immunotherapy

Jarret Glasscock, Ph.D., CEO, Cofactor Genomics

Dr. Jarret Glasscock has spent the last 18 years leading teams developing RNA technologies. An expert in interrogating nucleic acid sequences, Jarret participated in The Human Genome Project, the sequencing of the 1st Cancer Genome (AML), and has developed key technologies aimed at taking big data applications (such as RNA) out of research and into the clinic. Jarret is co-founder and CEO of Cofactor Genomics, and an alumni of the Y Combinator program.

Chris Meda, Chief Business Officer, Executive, IncellDx

No Bio Available

Bruce Patterson, Ph.D., CEO, Co-Founder, Executive, IncellDx

Dr. Patterson, CEO/Founder of IncellDx, has authored over 100 manuscripts and book chapters. He was Medical Director of Diagnostic Virology at Stanford Hospital and Clinic. CDx kits are developed and sold to laboratories worldwide and support the therapeutic products of our pharma partners. More about Single Cell Quantitative Cellular Multiplex™ technology www.incelldx.com

Marlon C. Rebelatto, DVM, Ph.D., Dipl. ACVP, Principal Pathologist, Translational Sciences, MedImmune

Marlon Rebelatto received his Doctor in Venterinary Medicine degree in Brazil, a Master’s in Epidemiology and Public Health and a PhD in Immunology at Purdue University. He then completed a residency in Pathology at Purdue University and is a Diplomat of the ACVP. Marlon worked for 7 years at MPI Research, evaluating pathology in a wide variety of toxicity studies and served as Director of Immunotoxicology. In 2009, Marlon joined MedImmune (a member of the AstraZeneca group) where he collaborates in many aspects of drug development, including target identification and validation, preclinical and clinical trial biomarker development and assessment, and companion diagnostics development. He has co-authored several papers and book chapters, has filed patents, and presented extensively in the use of tissue-based biomarkers in preclinical and clinical trials.

Nicholas P. Restifo, M.D., Principal Investigator, National Cancer Institute, NIH

Dr. Restifo pioneered the use of T cell-based immunotherapies. The Restifo group was amongst the first to identify myeloid-derived cell subsets that impair anti-tumor T cell responses. His work on immunoablation underlies many of the current generation of cellular therapies in the clinic. Dr. Restifo’s group was the first to discover a novel subset of long-lived human T memory stem cells in humans. More recently he has elucidated the role of basic elements, including oxygen and potassium, in achieving success of cancer immunotherapy. These fundamental discoveries are aimed at improving the treatment of adults and children with metastatic cancer.

Brent Wood, M.D. Ph.D., Professor, Laboratory Medicine and Pathology, Director, Hematopathology Laboratory and SCCA Pathology, Medical Director, SCCA Laboratories, University of Washington

Dr. Wood is Director of the Hematopathology and SCCA Pathology Laboratories and Medical Director of SCCA Laboratories. His professional responsibilities include the clinical diagnosis of hematopoietic disease and teaching hematopathology to medical technology students, medical students, residents and fellows. Flow cytometry has been an area of particular interest for Dr. Wood and he was responsible for implementing the first use of 9- and 10-color flow cytometry in the clinical laboratory, as well as subsequently exploiting its potential for the identification of minimal residual disease in acute lymphoid and myeloid leukemias. Dr. Wood's laboratory serves as one of two national reference laboratories for the flow cytometric identification of minimal residual disease in childhood acute lymphoblastic leukemia for the Children’s Oncology Group, is involved in similar protocols with the Southwest Oncology Group, and provides reference testing for multiple industry partners. As an extension of this work, Dr. Wood has pioneered studies to investigate the application of next-generation sequencing for minimal residual disease detection in both acute lymphoid and myeloid leukemias. Future work is focused on further refining both flow cytometric and molecular techniques for post-therapeutic monitoring in acute leukemia with an eye to single cell molecular analysis as the ultimate goal. Dr. Wood lectures both nationally and internationally on clinical applications of flow cytometry and is past president of the International Clinical Cytometry Society.

Coverage and Reimbursement of Advanced Diagnostics

Suzanne Belinson, Ph.D., MPH, Executive Director, Clinical Markets, Blue Cross and Blue Shield Association (BCBSA)

Suzanne Belinson, Ph.D., MPH, is the Executive Director of Clinical Markets at the Blue Cross and Blue Shield Association (BCBSA), a national federation of 36 independent community-based and locally operated Blue Cross and Blue Shield companies. The Blue system is the nation’s largest health insurer covering over 100 million- one-in-three Americans. As the Executive Director, Dr. Belinson leads the sales and market development for products and services developed within the Office of Clinical Affairs. In addition, as part of the leadership team in the Office of Clinical Affairs she focuses on the development of emerging programs and services that enhance value and brand leadership for the independent BCBS Plans. Before joining BCBSA, Dr. Belinson served as a NIH Clinical Cancer Fellow at Northwestern University where her work focused on community based interventions. Dr. Belinson developed and tested community based models for cervical cancer screening with both domestic and international applications. Dr. Belinson continues to serve as adjunct faculty at Northwestern University. Dr. Belinson received her bachelor’s degree from Cleveland State University, and a PhD in Epidemiology from the University of North Carolina at Chapel Hill. She also holds a Masters in Public Health from the University of Pittsburgh

David Cavanaugh, Partner, DeciBio Consulting

David Cavanaugh is a partner at DeciBio Consulting and the practice lead for clinical diagnostics. He has extensive experience assisting clients with opportunity identification, franchise expansion, growth strategy development, and new product developments. Prior to joining DeciBio, David was a Senior Manager at LEK Consulting and a bioinformatician at Genentech and GSK. He holds a B.S. in chemical engineering from the University of Virginia and an M.B.A. from the Kellogg School of Management.

Jerry Conway, Vice President, Payer Relations & Reimbursement, Foundation Medicine, Inc.

Jerry Conway, Vice President of Payer Relations & Reimbursement, joined Foundation Medicine Inc. in May 2012 with over 22 years of sales and executive management experience in the routine clinical and esoteric laboratory marketplaces working first in physician sales and marketing, then later with national and regional payers on contracting, education and utilization management initiatives involving laboratory services. His experience includes payer contracting and reimbursement in a wide range of business environments including Fortune 500 and start-up companies. In 2011, Jerry joined Metamark Genetics Inc., a national provider of cancer prognostic tests and services, as Vice President of Reimbursement & Payer Contracting. At Metamark, Jerry was responsible for payer strategy development for several assays in the pre-launch phase. In 1997, Jerry joined Genzyme Genetics, a national provider of genetic health services, to develop business relationships and contracts with regional and national payers based in the Northeastern United States. In 2001, he was promoted to the role of Director of National Accounts with Genzyme Genetics and was responsible for business development and contracts with national and cross-regional payers. In 2004, Jerry was promoted to Vice President of Managed Care where he oversaw a staff of 11 regional and national account directors who were focused on payer account management, contracting, pull through, education and care management programming. With a particular focus on reimbursement for routine and novel genetic tests and services in the reproductive and oncology markets at Genzyme Genetics, Jerry has a demonstrated track record of increased revenue and profitability. Under his leadership in payer contracting and reimbursement over 14 years, Jerry helped to favorably position the company for a recent $975 million acquisition by Laboratory Corporation of America® Holdings on December 1, 2010.

Kyle Fetter, Vice President & General Manager, Diagnostic Services Operations, MDx Support Services, XIFIN

Kyle has implemented and oversees the commercialization and reimbursement processes for the Diagnostic Services division which delivers SaaS based RPM systems to complex diagnostic companies. He assists companies on projecting cash flow for non-covered services, implementing successful appeals strategies, and effectively managing the relationship between sales and reimbursement for new medical technology.

Charles Mathews, Vice President, Boston Healthcare Associates

Mr. Mathews has worked on a variety of diagnostic reimbursement projects involving the analysis, development, and implementation of coding, coverage, and payment strategies for emerging and established innovators. This includes commercializing 100+ test products in cancer, diabetes, and cardiovascular and infectious diseases. Mr. Mathews has expertise in the development of global market access plans for companion diagnostics.

Dave Nellesen, Ph.D., Vice President, Analysis Group

Dr. Nellesen has successfully led many projects to commercialize new technologies for the pharmaceutical, molecular diagnostic, and medical device industries. He helps clients develop clinical and economic evidence to secure favorable coverage and reimbursement. This work includes strategic planning, real-world evidence generation, health economic modeling, and formulary or value dossiers to communicate this evidence. While at Analysis Group, Dr. Nellesen has supported the launch of more than 30 new drug products.

Victoria M. Pratt, Ph.D., FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Department of Medical and Molecular Genetics, Indiana University School of Medicine

Dr. Pratt is a Medical and Clinical Molecular Geneticist board-certified by the American College of Medical Genetics. She is the Director of the Pharmacogenomics Laboratory and Molecular Genetics Laboratory at Indiana University School of Medicine. Prior to joining Indiana University, she was Chief Director, Molecular Genetics, for Quest Diagnostics Nichols Institute. In addition to her work, Dr. Pratt is currently serving on the Centers for Medicare and Medicaid Services Clinical Diagnostic Laboratory Tests Advisory Panel. Dr. Pratt also serves on the American Medical Association’s (AMA’s) Molecular Pathology Current Procedural Terminology (CPT) Advisory and Proprietary Laboratory Assay Technical Advisor committee.

Bas van der Baan, Chief Clinical and BD Officer, Medical Affairs, Agendia

Bas van der Baan is the Chief Clinical and Business Development Officer at Agendia. He joined Agendia in 2004 shortly after its founding and has held various leadership positions within the company. In his current role he is responsible for Agendia’s prospective and retrospective clinical trials, intellectual property and scientific collaborations and reimbursement. He played an instrumental role in Agendia’s involvement in the MINDACT trial and ISPY 2 trial. MINDACT is the first prospective randomized trials with the biomarker as primary end point and the positive outcome was published in August 2016 in the NEJM. The ISPY 2 trial is a molecular diagnostic driven adaptive neo adjuvant trial in breast cancer in collaboration with the FDA to expedite approval in the (neo) adjuvant setting of promising new drugs. With a background in biochemistry and molecular biology, Bas began his scientific career at Unilever Research and has over 18 years collective experience in biotechnology and molecular diagnostics

Robert Remstein, MBA, Vice President, Capital Health

As the Vice President for Accountable Care, Dr. Remstein is responsible for Capital Health’s moves toward becoming a leader in population health. He works with other members of the hospital leadership team to develop the outpatient network, and programs that address clinical integration across the care continuum; helping Capital Health to remain competitive in the changing health care environment. Prior to his current position, Dr. Remstein served as vice president of Medical Affairs at Capital Health. He has been a member of the Capital Health medical staff for more than 27 years serving in many voluntary leadership positions. Dr. Remstein is a founding member and current president of the Trenton Health Team, an organization supported by Capital Health to further the development of an urban accountable care organization. His background as a physician practicing in the community, coupled with his successful experience in working with his colleagues on the Capital Health medical staff on matters ranging from the clinical to administrative, uniquely qualifies him for this important position.Dr. Remstein received his medical degree from New York College of Osteopathic Medicine and completed a residency in internal medicine at Albert Einstein Medical Center, PA. He previously served as Medical Director of Henry J. Austin Health Care Center in Trenton, and was a founding member of Mercer Internal Medicine Associates. He is also a practicing internist and is the Medical Director of Capital Health Primary Care – Lower Makefield in Yardley, PA.

Companion Diagnostics: Strategy & Partnerships

Shirin Ford, Ph.D., Executive Director, Global Head Biomarker & Diagnostics, Oncology Global Medical Affairs, Merck

Shirin Khambata Ford, PhD is Executive Director, Biomarker and Diagnostics at Merck (MSD) Oncology. She is the Global Medical Head for biomarker and diagnostic activities for KEYTRUDA (anti-PD1) and other assets in the Merck Oncology Business Unit. Over the past 15 years Dr. Khambata Ford has held various leadership positions in Oncology Precision Medicine. She was Executive Director, Global Head of Correlative Sciences in Oncology Global Development and Medical Affairs at Novartis. She built and led a group that is focused on developing Oncology Biomarkers and supporting translational research activities for Oncology full development programs. Prior to this Dr. Khambata Ford was as a Senior Biomarker & Experimental Medicine Leader at Roche Pharma Research & Early Development. She also served as Director, Clinical Biomarkers Oncology at BMS where she led a group responsible for the discovery, validation and strategic implementation of predictive and pharmacodynamics biomarkers. Her key accomplishments include being the lead researcher on the team that discovered that EGFR ligand gene expression and K-ras mutation status are predictive markers of benefit from cetuximab (anti-EGFR monoclonal antibody therapy) in metastatic colorectal cancer. As the Biomarker Lead on cetuximab for over eight years, Dr. Khambata Ford was a key participant in regulatory and diagnostic activities in addition to providing scientific leadership and expertise.

Gary Gustavsen, Partner, Personalized Medicine, Health Advances

Gary Gustavsen joined Health Advances in 2005 and leads its Personalized Medicine Practice. A noted writer and workshop leader in the field of companion diagnostics and personalized medicine, his work focuses on commercialization strategy, indication prioritization, pricing and reimbursement strategy, system economics, and business development opportunities for both diagnostic and therapeutic clients. Prior to joining Health Advances, Gary was a researcher at Brookhaven National Lab evaluating a proprietary line of synthetic growth factors. Gary also worked in the Cell & Tissue Technologies group at Becton Dickinson, the Exploratory Cancer Research group at OSI Pharmaceuticals, and most recently the Corporate Strategy group at Millennium Pharmaceuticals. Gary received his Bachelors degree in Biomedical Engineering from Duke University and his Masters degree in Biomedical Engineering from Stony Brook University.

Pavel Khrimian, Associate Director, Partnering & Strategy, MedImmune

Pavel Khrimian is an experienced professional in the biopharmaceutical industry with a diverse portfolio experience. Mr. Khrimian joined MedImmune in 2010, where he currently holds a position of an Associate Director, Partnering & Strategy. In this role, he is responsible for identifying and executing a broad spectrum of strategic industry and academic partnerships in the field of Diagnostics, Digital Health and early discovery to clinical collaborations.

Joseph Krueger, Ph.D., CSO, Flagship Biosciences

Joseph is the CSO of Flagship Biosciences Inc, a company who helps drug developers leverage the benefits of tissue-based biomarkers by improving pathology based strategies. His biomarker and drug development experience at OSI Pharmaceuticals and Pfizer helped build an interdisciplinary team who create novel tissue endpoints supporting critical clinical trial decisions. At Flagship, he continues to leverage his experience successfully to grow the largest clinical tissue image analysis service company in the US.

Michael C. Montalto, Ph.D., Executive Director, Translational Pathology & Biomarker Technologies,Translational Medicine, Bristol-Myers Squibb

Dr. Montalto is a research and development leader with a broad range of experience at the executive level including R&D, clinical, regulatory, medical and scientific affairs. He is currently the Executive Director and Head of Translational Pathology and Biomarker Technologies in Translational Medicine at Bristol-Myer Squibb. In this role he leads genomics, genetics, flow cytometry, histo-chemistry and pathology laboratories in support of clinical trials, exploratory biomarker research and companion diagnostics. Prior to this role, Dr. Montalto was a co-founder and executive of Omnyx, LLC, a joint venture of GE Healthcare and the University of Pittsburgh Medical Center that commercialized diagnostic pathology imaging and software products. He has patented and published on novel pathology-based multiplexing technology (MultiOmyx™, Clarient/Neogenomics) for oncology biomarker discovery. He has designed and led global clinical trials for in vitro diagnostic digital pathology devices and served as chair of the regulatory taskforce of the Digital Pathology Association (DPA). He currently sits on the board of directors as President-elect of the DPA. He has served as a member of NIH study sections for in vivo molecular imaging centers. Dr. Montalto earned his PhD in tumor biology from Albany Medical College and received his post-doctoral training in anti-inflammatory drug discovery and whole animal physiology at Brigham and Women’s Hospital, Harvard Medical School.

Jonathan Pan, Ph.D., MBA, Vice President, Head of Biomarker Strategy and Development, Aevi Genomic Medicine

Jonathan is currently VP, Head of Biomarker Strategy and Development at Aevi Genomic Medicine, a biotechnology firm focused in translating genetic discoveries into novel therapies to improve the lives of children and adults with pediatric onset life altering diseases. At Aevi, he is focused on bringing precision medicine and companion diagnostic testing to diseases outside of oncology, such as ADHD and IBD. Prior to Aevi, Jonathan led competitive strategy for the I-O franchise at BMS and was the Head of Oncology Companion Diagnostics and Disease Strategy at GSK, leading launch activities for companion diagnostic testing globally. He was a former management consultant at Deloitte, IMS Consulting and Scientia Advisors. He has a PhD and MBA from the University of Michigan.

Omar D. Perez, Ph.D. RAC, Senior Director Diagnostics, Oncology, Worldwide R&D, Pfizer

Dr. Perez has over 15 years of experience in diagnostic and drug development. He currently oversees global companion diagnostic development activities for the oncology portfolio at Pfizer and has led a variety of CDx product launches for Xalkori. He previously served as the Director for R&D Diagnostics at Tocagen where he led the preclinical and diagnostic assay development efforts for Toca 511, a gene therapy product for glioblastoma. Prior to Tocagen, Dr. Perez was the Senior Director of Research and Technology at Nodality Inc., a diagnostic company he co-founded. Prior to Nodality, Dr. Perez was the Senior Scientist and Director of the phospho-protein flow cytometry group at the Stanford Proteomics Center in the Stanford Medical Center, overseeing project management for antibody screening procedures, autoimmune clinical studies, and small compound profiling for many major pharmaceutical companies. During his time at Stanford, he developed several proteomic related systems for functionally characterizing signaling networks in single cells. He is an inventor of the multiparametric phospho-proteomic flow technologies and an author of 37 publications and 35 patents. Dr. Perez is recipient of several prestigious awards including the Herzenberg Prize, the Human Immunology Award Dana Foundation, the Bristol Myers Squibb-Irvington Award, a Kauffman Fellow and several Pfizer UpJohn prizes.Dr. Perez received his doctorate in Molecular Pharmacology from Stanford University. He holds a B.A in both Molecular Biology and Philosophy with distinction and Chemistry degrees from the University of California, Berkeley. He received an executive education certificate in management and leadership at the MIT Sloan School of Management and has a Regulatory Affairs Certification.

Pascal Puchois, CEO, Trans-Hit Bio

Dr Pascal Puchois is the founder and the Chief Executive Officer of Trans-Hit Bio. He is the reference scientific person within the company for project management purposes and leads the development of the partnered network of biobanks and R&D collaborators.

Koustubh Ranade, Ph.D., Vice President, Translational Medicine, MedImmune

Koustubh Ranade is Vice President, Translational Medicine at MedImmune with responsibility for developing biomarkers and companion diagnostics for oncology, respiratory, inflammatory and autoimmune diseases. His group has discovered and is developing novel predictive biomarkers for therapeutics in development for multiple cancers, severe asthma, atopic dermatitis, Crohn’s, rheumatoid arthritis and lupus. Prior to MedImmune, he was at Genentech and Bristol-Myers Squibb. He has published extensively on human genetics and pharmacogenomics; co-authored and edited a book on the application of genomics to drug development, and is an inventor on four issued patents. Koustubh received his PhD from the University of Massachusetts Medical School, and did postdoctoral work at the National Human Genome Research Institute of the NIH and at the Stanford University School of Medicine.

Mitch Raponi, Ph.D., Vice President, Molecular Diagnostics, Clovis Oncology

Mitch Raponi, PhD, is Vice President and Head of Molecular Diagnostics at Clovis Oncology. Dr Raponi is responsible for designing and executing companion diagnostic strategies to support the development and commercialization of effective cancer therapeutics. Clovis’ development programs are targeted at specific subsets of cancer, combining personalized medicine with companion diagnostics to direct therapeutics to those patients most likely to benefit from them. The lead product candidate under active development is rucaparib, an oral inhibitor of poly (ADP-ribose) polymerase (PARP), which is in advanced clinical development for the treatment of ovarian cancer. In partnership with Foundation Medicine novel companion diagnostics are being developed to support approval of rucaparib. Dr Raponi previously spent 15 years at Johnson & Johnson, building biomarker and companion diagnostic programs within the diagnostics and pharmaceutical franchises. He received his PhD in Molecular Genetics and Biochemistry from the University of New South Wales, Australia, and has published in the fields of gene therapy, cancer genomics, and personalized medicine.

Seema Singh Bhan, Head of Public Policy, Foundation Medicine

Seema Singh Bhan is Head of Public Policy for Foundation Medicine. She brings with her nearly 15 years of Hill-based experience -- serving as senior counsel to Senator Arlen Specter where she was lead policy and strategic advisor for all issues related to tax, banking, healthcare, finance, among other topics. Additionally, Seema was also lead counsel to Chairman Specter while he led the Senate Judiciary Committee providing policy analysis and strategic counsel to both Chairman Specter and to other Republican and Democrat senators on the Senate Judiciary Committee. She has extensive experience working closely with members of the Executive branch, think tanks, economic stakeholders, and grassroots organizations.

Dan Snyder, President & CEO, MolecularMD

Mr. Snyder has been at MolecularMD since its inception in 2006 and assumed the role of President and CEO in 2014. With over 17 years of experience in the life science research and diagnostic fields, Mr. Snyder has worked extensively in supporting new product introductions and rapid market adoption for novel proteomic and genomic technologies. He received a BA from the University of Virginia and an MBA from the College of William and Mary.

Gary Spitzer M.D., Director Clinical Validity and Clinical Utility Evaluation, MolDx, Palmetto GBA

Dr. Gary Spitzer presently evaluates the clinical utility of precision medicine testing for potential full coverage or possible coverage with data development under the requirement of a well-designed, prospectively developed outcome protocol and associated registry or trial. He is a Medical Oncologist by training. He graduated medical school in Melbourne Australia and received his medical oncology training and clinical research experience at MD Anderson Hospital Houston Texas. His present interests focus on the evidence-based clinical utility of precision medicine tests, and particularly cell-free DNA and other liquid biopsies techniques.

Richard Watts, Vice President, Companion Diagnostic Partnerships. Global Business Development, QIAGEN

Richard Watts is Vice President of Business Development for Companion Diagnostic Partnerships and Personalized Healthcare at QIAGEN. Working to establish collaborations and diagnostic development programs with pharmaceutical companies, Richard consults on technology, clinical and regulatory aspects that support the strategic, operational and commercial elements of drug-diagnostic co-development programs. Richard has worked in partnership with pharma for the pre-launch and launch of KRAS and EGFR testing on a global basis. In the 8 year tenure within his current role in business development, he has structured many companion diagnostic co-development programs, master collaboration agreements and other transactional deals in the space of personalised healthcare. Richard also has a role in the scouting and diligence of new enabling technologies for diagnostic application.Prior to his position in business development he managed and implemented QIAGEN’s marketing strategy in the pharmaceutical sector with a focus on translational medicine and pharmacogenomics. Before joining QIAGEN Richard held senior managerial, commercial and technical positions at Invitrogen, Nanogen, Packard and Bio-Rad. Richard is a member of the Royal Society of Medicine and graduated in molecular and cellular biology from the University of Bath.

Katarina Wikstrom, Ph.D., Director, US Operations, Almac Diagnostics, Almac Group

Dr. Katarina Wikstrom (PhD) has worked for over 14 years in translational molecular oncology and holds the position of Head of US Operations at Almac Diagnostics. Katarina has overall responsibility for all US laboratory technologies and services supporting biomarker discovery, assay development and validation, and product delivery. Katarina obtained a PhD in experimental pathology from Lund University, and completed a postdoctoral fellowship at University College Dublin.

Pharmacy-Based Point-of-Care Testing

Alex Adams, Pharm.D., MPH, Executive Director, Idaho State Board of Pharmacy

Alex Adams, PharmD, MPH, is Executive Director of the Idaho State Board of Pharmacy. Prior to this, he served as Vice President of Pharmacy Programs at the National Association of Chain Drug Stores (NACDS), a Washington, DC-area trade association that represents 40,000 pharmacies in the United States.

Betty J. Dong, Pharm.D., FASHP, FAPHA, FCCP, AAHIVP, Professor, Clinical Pharmacy and Family and Community Medicine, University of California Schools of Pharmacy and Medicine

Betty J. Dong, PharmD, CSHP, FASHP, FCCP, FAPHA, AAHIVP, is Professor of Clinical Pharmacy at University of California Schools of Pharmacy and Family and Community Medicine. She received her PharmD from UCSF in 1972 and then completed a clinical pharmacy residency at UCSF in 1972. Betty holds a joint appointment in the Department of Family and Community Medicine.

She is a clinician for the Clinicians' Consultation Center (CCC), a national telephone consulting service funded by the CDC and HRSA for the management, including pre-exposure and post-exposure prophylaxis, for HIV, HBV, and HCV infection in adults, children, and during pregnancy.

Betty’s clinical practice functions under a collaborative prescribing protocol. These clinics include the Family HIV/HCV clinic and a Family Medicine clinic for the referral of difficult-to-manage patients with chronic diseases, including hepatitis C, HIV, hypertension, anticoagulation, diabetes, non-adherence, and medication reconciliation. AT UCSF, she provides HCV education and follow-up assessment for chronic HCV+ and HIV/HCV co-infected patients, including pre and post liver transplants. Betty has extensively published and lectured in the aforementioned areas.

Suzanne Higginbotham, Pharm.D., BCACP, Director, Duquesne University Pharmacy

Suzanne K. Higginbotham is the Director of the Duquesne University Pharmacy at Duquesne University and certified as an ambulatory care specialist. She received her Bachelor of Science degree in chemistry and biology from The Ohio State University prior to completing her Doctor of Pharmacy degree at Duquesne University. She went on to complete a two year Academic and Research Fellowship at Duquesne University with a focus in ambulatory care. Upon graduation from the fellowship program, she was hired as the Director of the Center for Pharmacy Care, an ambulatory care center located on Duquesne University’s campus. In 2016, The Center for Pharmacy Care merged with the Duquesne University Pharmacy and Dr. Higginbotham directs both entities. Dr. Higginbotham’s clinical responsibilities at her site involve the implementation of various programs including employee wellness and disease state management, student wellness and preventative care services, full service immunization and travel medicine activities, and other medication and disease state therapy management. Dr. Higginbotham’s current areas of research are in pharmacist directed immunization practices along with implementation of comprehensive medication therapy management in various group settings. Dr. Higginbotham currently teaches business planning and advanced pharmacy practice skills in the School of Pharmacy as well as serving as the Director of Residency programs at Duquesne University.

Edana Holliday, Pharm.D., Clinical Pharmacist, Community Ambulatory Care Services, Rx Clinic Pharmacy; Vice President, Communications, Pharmacogenetics Center of Excellence

No bio available.

Donald Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center

Donald G. Klepser, PhD, MBA, is associate professor and vice chair of pharmacy practice at the University of Nebraska Medical Center, College of Pharmacy. He has PhD in Pharmaceutical Socioeconomics from the University of Iowa, an MBA from the University of Minnesota’s Carlson School of Management, and a Bachelors degree in Communications from the University of Michigan. He has studied the use of POC testing in community pharmacies for the past 9 years and is currently the primary investigator on grants to develop community pharmacy practice models for managing diseases such as HIV, HCV, influenza, and group A Streptococcus. He is also the primary investigator on grants to better understand how state and local health departments perceive the role of pharmacists conducting POC tests.

Michael Klepser, Pharm.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy

Dr. Klepser received his Doctor of Pharmacy from the University of Michigan College of Pharmacy in 1992. He has completed a pharmacy practice residency at Detroit Receiving Hospital and University Health Center and a fellowship in infectious diseases at Hartford Hospital in Hartford, Connecticut.

Dr. Klepser has been a Professor of Pharmacy at Ferris State University since 2001. Prior to joining Ferris, he was an Associate Professor at the University of Iowa College of Pharmacy (1995-2001). Dr. Klepser’s research interests include use of point-of-care tests in community pharmacies and community-based antimicrobial stewardship. He has published extensively on these topics and has more than 130 peer-reviewed manuscripts to his credit. Dr. Klepser is a founder and content advisor for the “Community Pharmacy-Based Point-of-Care Testing” certificate program. Dr. Klepser is active in several professional organizations including the Society of Infectious Diseases Pharmacists, the American College of Clinical Pharmacy, and the Infectious Diseases Society of America.

Alexander Sbordone, J.D., OTR/L, Senior Advisor, Operations, MinuteClinic, CVS Health

Alexander Sbordone, JD, OTR/L is a Senior Advisor of Ambulatory Operations for CVS Health/MinuteClinic. In this position, his responsibilities include the strategic and day to day operations of over 1100 clinics throughout the country. Additionally, he oversees the organization of laboratory services at MinuteClinic comprising of all point of care testing performed within the clinics, relationships with all current and potential laboratory services vendors, and reference laboratory management. Mr. Sbordone received his JD from Suffolk University with a concentration in Heath and Biomedical Law, and a Bachelor’s degree in Occupational Therapy from Quinnipiac University.

Heather L. Stang, Deputy Branch Chief, Laboratory Practice Standards Branch, Division of Laboratory Systems, Centers for Disease Control and Prevention (CDC)

Mrs. Stang is currently the Deputy Branch Chief of the Laboratory Practice Standards Branch in the Division of Laboratory systems at the Centers for Disease Control and Prevention. She is involved in the development and evaluation of regulatory and voluntary standards and guidelines, management of the Clinical Laboratory Improvement Advisory Committee (CLIAC, and provision of technical assistance and consultation on laboratory standards and laboratory practices.

Blair Thielemier, Pharm.D., Pharmacy Consultant, BT Pharmacy Consulting

The last two years Blair’s primary focus has been elevating the profession of pharmacy through advanced clinical services. She regularly shares information about pharmacy consulting services on her blog at BTPharmacyConsulting.com, through her column at Pharmacy Times and by guest-hosting the internet radio show The Pharmacy Podcast. Blair is the author of the Amazon bestselling book How to Build a Pharmacy Consulting Business.

She is the founder of Pharmapreneur Academy, an online teaching platform where she guides pharmacist-entrepreneurs through the process and barriers of building a pharmacy consulting business.

Blair believes the shift to value-based instead of volume-based pharmacy services is an opportunity pharmacists should actively pursue. Using the power of the internet, she has been dedicated to sharing information on pharmacist billing options, collaborative practice models, point of care testing programs and marketing pharmacy services.

Her career has developed around helping community pharmacies in Northeast Arkansas, providers in primary care and post acute care stakeholders improve CMS quality measures. For the past two years, Blair has been building an independent MTM consulting business with the goal of helping busy independent community pharmacies improve quality measures and decrease penalty fees. She helps pharmacies build clinical service programs, such as MTMS, immunization and smoking cessation programs using collaborative practice agreements.

She has completed the APhA MTM and Immunization Certifications. In 2016, she was responsible for building and presenting the ACPE accredited Community Pharmacy MTM Enhancement Workshop.

Andrea G. Vastis, MPH, Senior Manager, Pharmacy Product Development, Patient Care Programs, CVS Health

Andrea Vastis has over 20 years of experience in public health programming spanning Payers, Government agencies, Academia and Healthcare. She received her BS in Health Education from Rhode Island College and her MPH in Social and Behavioral Sciences from Boston University. Her professional experience includes Employee Wellness, Chronic Disease Prevention & Control, Academic preparation and healthcare product development. In addition to her role at CVS, she consults with community-based organizations in translating behavior change theory to practice for fire, fall and home safety efforts.

Molecular Diagnostics for Infectious Disease

Ritu Banerjee, M.D., Ph.D., Associate Professor, Pediatric Infectious Diseases, Vanderbilt University Medical Center, Director of Pediatric Antimicrobial Stewardship, Monroe Carell Jr. Children’s Hospital at Vanderbilt

Dr. Banerjee is an Associate Professor in the Division of Pediatric Infectious Diseases at Vanderbilt University Medical Center and Director of the Antimicrobial Stewardship Program at Vanderbilt’s Children’s Hospital. She received her M.D. and Ph.D. degrees from Washington University in St. Louis and then completed Pediatrics residency and Pediatric infectious disease fellowship at the University of California, San Francisco. She is a member of the Infectious Disease Society of America Diagnostics Committee, and the Pediatric Infectious Disease Society’s Committee on Antimicrobial Stewardship. In addition to providing clinical care for children with complicated infections, Dr. Banerjee is active in clinical research related to surveillance of antibiotic-resistant bacterial pathogens and strategies to optimize appropriate antibiotic use. She is currently the principal investigator on an NIH-funded multicenter trial to evaluate the impact of a rapid diagnostic combined with antimicrobial stewardship intervention on outcomes of Gram negative bacteremia.

Charles Chiu, M.D., Ph.D., Associate Professor of Laboratory Medicine and Medicine, Division of Infectious Diseases at University of California, San Francisco, Director of the UCSF-Abbott Viral Diagnostics and Discovery Center (VDDC), and Associate Director of the UCSF Clinical Microbiology Laboratory

Dr. Charles Chiu, M.D., Ph.D., is an Associate Professor in Laboratory Medicine and Medicine, Infectious Diseases at the University of California, San Francisco. He is also the Director of UCSF-Abbott Viral Diagnostics and Discovery Center (VDDC) at China Basin and Associate Director of the UCSF Clinical Microbiology Laboratory. Charles is an expert in the emerging field of clinical metagenomics, and his research is focused on the development and validation of microarray and next-generation sequencing (NGS) technologies for viral discovery and pathogen diagnostics, with over 20 patents and peer-reviewed publications on these topics. In addition, he is the principal investigator of a 5-year R01 grant from the NIH on multiplexed blood bank pathogen screening, California Discovery, UC-MEXUS, and National Research Fund for Tickborne Diseases (NRFTD) grants on the microbial epidemiology of encephalitis, diarrhea, and Lyme disease, a QB3 Rogers Family Foundation Award in translational diagnostics, and a UCSF-Abbott Viral Discovery Award. Charles is also an active practicing infectious diseases physician at UCSF. Charles has active collaborations with research groups and public health agencies worldwide, including Abbott Diagnostics, Inc., Blood Systems Research Institute, the California Department of Public Health, the United States CDC, the American Red Cross, and the Texas Biomedical Research Institute.

Rita Colwell, Ph.D., Distinguished Professor, University of Maryland at College Park and Johns Hopkins University Bloomberg School of Public Health

Dr. Rita R. Colwell is Distinguished University Professor at the University of Maryland, College Park and Johns Hopkins University Bloomberg School of Public Health and Chairman and Chief Science Officer, CosmosID, Inc. Her interests are focused on genomics, biodiversity, and molecular microbial systematics and ecology. Dr. Colwell is an honorary member of the microbiological societies of the UK, Australia, France, Israel, Bangladesh, India and the U.S. Dr. Colwell served as the 11th Director of the National Science Foundation from 1998 to 2004. She has authored/co-authored 19 books and over 700 scientific publications. She is a member of the National Academy of Science and has been awarded the Stockholm Water Prize, Order of the Rising Sun, Japan, and the US National Medal of Science.

Eran Eden, Ph.D., Co-founder and CEO, MeMed

As CEO and Co-founder, Dr Eden has led MeMed from concept to flourishing company. He holds a BSc in Computer Engineering, BA in Biology, MSc in Computer Science from the Technion, and a PhD in Systems Biology from the Weizmann Institute. Dr Eden is co-author of over 20 patents and 18 publications.

Ferric C. Fang, M.D., Professor of Laboratory Medicine, Microbiology and Medicine, University of Washington School of Medicine

Ferric C. Fang, M.D., is an infectious diseases specialist and medical microbiologist with thirty years’ experience as a clinician, educator and researcher. He obtained his undergraduate and medical training at Harvard University and his residency and fellowship training at UCSD. He is currently a Professor of Laboratory Medicine, Microbiology and Medicine at the University of Washington School of Medicine and the Director of Clinical Microbiology at Harborview Medical Center. He is also Editor-in-Chief of Infection and Immunity, Deputy Editor of Clinical Infectious Diseases, and an elected fellow of the American Association for the Advancement of Science, the Association of American Physicians, the American Academy of Microbiology and the American Society of Clinical Investigation.

Robert K Ernst, Ph.D., Professor and Vice Chair, Department of Microbial Pathogenesis, University of Maryland – Baltimore

Robert (Bob) K Ernst is a Professor and Vice Chair of the Department of Microbial Pathogenesis at the University of Maryland - Baltimore. His focus there is on development of microbiological diagnostics and therapeutics based on affecting or circumventing normal host innate immune system responses to TLR4 ligands. Recently, he and longtime collaborator David Goodlett of the University of Maryland School of Pharmacy founded Pataigin LLC of Baltimore, MD to focus on commercialization of a novel bacterial and fungal diagnostic platform.

David R. Goodlett, Ph.D., Professor, Pharmaceutical Sciences, University of Maryland School of Pharmacy

David R Goodlett is since 2013 a Professor of Pharmaceutical Sciences at the University of Maryland School of Pharmacy. His focus is on development of microbiological diagnostics and therapeutics based around lipid A. From 2012-2016 he was a Finland Distinguished Professor at the University of Turku. From 2004-2012 he was Professor of Medicinal Chemistry at the University of Washington. Prior to his nine-year term there, he was Director of the Institute for Systems Biology’s Proteomics laboratory (2000-2003). Most recently he and longtime collaborator Robert Ernst of the University of Maryland Dental School founded Pataigin, LLC of Baltimore, MD to focus on commercialization of a novel bacterial and fungal diagnostic platform.

Elena Grigorenko, Vice President, Research and Development, Diatherix, Eurofins Clinical Diagnostics, LLC

Dr. Elena V. Grigorenko has over 15 years’ experience across R&D and product development in the pharmaceutical and biotechnical industries and played an integral part in several successful commercial product launches. Prior to joining Diatherix Laboratories, as Vice-President of Research and Development, she served as Associate Director at Life Technologies, where her responsibilities included leadership of a high-throughput PCR application team for scientific and business development programs and establishing collaborative studies in the area of genomics with leading academic, government and industrial researchers. She is author of more than 30 peer-reviewed publications and three patent applications and served on Scientific Advisory Board of NuGen Technologies. Dr. Grigorenko graduated with Honors from Saratov State University (USSR) and received her Ph.D. in Biochemistry from Institute of Biological Physics of Russian Academy of Sciences.

Jonathan Jacobs, Ph.D., Senior Advisor, Global Health and Surveillance, MRIGlobal

No Bio Available

Jason Kralj, Ph.D., Staff Scientist, Complex Microbial Systems Group, Biosystems and Biomaterials Division, Material Measurements Laboratory, NIST

Jason Kralj is the co-leader of NIST’s sequencing-based pathogen detection, focusing on developing standard methods and materials to address mixtures of microbes. Through interactions with government, academic, and private entities, the NIST team seeks to address the current challenges facing development of sequencing-based metagenomics analyses and expedite commercialization of the technologies. Dr. Kralj also has extensive experience in microfluidic-based technologies for chemical and biological applications.

Nathan Ledeboer, Ph.D., Associate Professor of Pathology and Medical Director, Medical College of Wisconsin

Dr. Ledeboer received his B.A. Degree from Dordt College in 2000 and his Ph.D. Degree in Microbiology from the University of Iowa in 2005. Following two years of fellowship training in clinical and public health microbiology at Washington University School of Medicine in Saint Louis, MO, he became an Assistant Professor of Pathology at the Medical College of Wisconsin and Medical Director of Clinical Microbiology and Molecular Diagnostics at Froedtert Hospital and Dynacare Laboratories in Milwaukee, WI where he has remained for more than 5 years. In addition to his service activities as director of clinical microbiology and molecular diagnostics at a large academic medical center, Dr. Ledeboer continues to develop his research career. His research endeavors, particularly in the area developing diagnostic tools for infectious diseases, have led to numerous publications in peer-reviewed journals. He has been Chairman of Public and Professional Affairs for the South Central Association for Clinical Microbiology and served on the American Society for Microbiology’s Clinical Microbiology Task Force. Dr. Ledeboer is currently a member of the American Board of Medical Microbiology Exam committee, a member of the Committee on Postgraduate Educational Programs through the American Society for Microbiology, and is the microbiology scientific program chair for The Association for Mass Spectrometry: Applications to the Clinical Laboratory. He is currently a member of the editorial board of the Journal of Clinical Microbiology and serves as an ad hoc reviewer for numerous other journals in infectious diseases and clinical microbiology. He has delivered nearly 100 invited lectures in various medical-scientific educational forums worldwide and has served as an investigator on more than 75 funded research projects. In 2011, he received the distinguished Siemens Young Investigator Award from the American Society for Microbiology.

Larissa S. May, M.D., Associate Professor, Department of Emergency Medicine, University of California, Davis

Larissa May, M.D., MSPH, MSHS, is an Associate Professor of Emergency Medicine and Director of Emergency Department Antibiotic Stewardship at the University of California-Davis. She is a national expert in antibiotic stewardship in the emergency department (ED). Dr. May received her M.D., her MSPH in Public Health Microbiology and Emerging Infectious Diseases, and her MSHS in Clinical and Translational Research from The George Washington University. Dr. May’s research interests center on clinical infectious disease epidemiology and management, with a particular focus on the application of rapid molecular diagnostic assays and clinical guidelines to improve antibiotic stewardship in the ED. Dr. May has served as an investigator on several federally-funded and industry-sponsored trials evaluating new molecular assays in the ED. She has published over 50 peer-reviewed articles. She has also served on committees and task forces for the Centers for Disease Control and Prevention and the National Institutes of Health and professional organizations including the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America.

Kevin Messacar, M.D., Assistant Professor of Pediatrics, University of Colorado/Children’s Hospital Colorado, Section of Infectious Diseases

Dr. Messacar is a pediatric infectious disease physician and researcher at the University of Colorado/Children’s Hospital Colorado. His research interests focus on improving the use of diagnostic tests for infectious diseases with a focus on central nervous system infections. He is interested in the process of selecting, implementing, and evaluating newly emerging rapid diagnostic technologies using concepts of diagnostic and antimicrobial stewardship. His current efforts include evaluating the clinical impact of rapid multiplex PCR panels and metagenomic sequencing of cerebrospinal fluid on children with suspected meningitis and encephalitis.

Christopher R. Polage, M.D., MAS, Associate Professor of Pathology and Infectious Diseases, University of California, Davis School of Medicine

Christopher Polage is an Associate Professor of Pathology and Infectious Diseases at the University of California Davis (UC Davis) and Director of the Clinical Microbiology Laboratory for UC Davis Health. He conducts outcomes and healthcare services research related to infectious disease diagnostics and healthcare-associated infections. He is on the Editorial Board for the Journal of Clinical Microbiology and received a Distinguished Clinical Research Achievement Award from the Clinical Research Forum in 2016 for his studies of clinical outcomes in hospitalized patients with discrepant test results for Clostridium difficile infection.

Robert Schlaberg, M.D., MPH, Medical Director, ARUP Laboratories, Assistant Professor of Pathology, The University of Utah

Matthew Sobansky, Ph.D., Research & Development, Senior Scientist, Molecular Technology, Streck

Matthew R. Sobansky is an R&D Senior Scientist at Streck in the Molecular Division. Dr. Sobansky received his Ph.D. in Chemistry from the University of Nebraska-Lincoln in 2014 where his work focused on affinity chromatography. His current research utilizes stabilization chemistry in the development of molecular diagnostic products and controls. Dr. Sobansky has previous experience in pharmaceutical product R&D, analytical method development, regulatory compliance, quality control/manufacturing, and management.

Richard Spero, Ph.D., CEO, Redbud Labs

Erin McElvania TeKippe, Ph.D., D(ABMM), Assistant Professor of Pathology and Pediatrics, University of Texas Southwestern Medical Center, Director of Clinical Microbiology, Children’s Health

Erin McElvania TeKippe is an Assistant Professor of Pathology and Pediatrics at the University of Texas Southwestern Medical Center and Director of Clinical Microbiology at Children’s Health, Dallas, Texas. She completed her Ph.D. in Microbiology and Immunology at the University of North Carolina at Chapel Hill followed by a fellowship in Medical and Public Health Microbiology at Washington University School of Medicine. Dr. McElvania TeKippe’s research interests include molecular microbiology along with rapid microorganism identification and antimicrobial susceptibility testing.

Ephraim L. Tsalik, M.D., Ph.D., Assistant Professor, Medicine, Duke University School of Medicine

Ephraim Tsalik is an Assistant Professor in the Department of Medicine, Division of Infectious Diseases. He also holds an appointment in the Emergency Department Service at the Durham VA Medical Center. He earned his M.D. and Ph.D. from Columbia University followed by residency and fellowship training at Duke University. He also obtained a Masters in Health Services with a focus on Clinical Research during his fellowship training at Duke. Dr. Tsalik is a leading member of the Acute Infectious Diseases Clinical Research Unit, headed by Drs. Geoff Ginsburg and Chris Woods. The focus of Dr. Tsalik's work is to explore the nature of host-pathogen interactions through genomic medicine technologies. This information provides insight into infectious disease pathophysiology. It can also be used to develop novel diagnostic tools for the clinical management of acute infectious diseases, which is the major focus of Dr. Tsalik's work.

Maryann Turnsek, Microbiologist, National Enteric Reference Outbreak (NERO) Team, NCEZID/DFWED/EDLB, Centers for Disease Control and Prevention (CDC)

Maryann Turnsek is a microbiologist in the Enteric Diseases Laboratory Branch (EDLB) at the CDC and a founding member of the Next Generation Sequencing (NGS) Quality Workgroup, addressing the development and implementation of best practices and quality standards for NGS users at the CDC. She also serves on the NGS Quality Review Board, whose mission is to provide recommendations and guidance to laboratories performing NGS in regards to quality goals, objectives, policies, procedures, and continuous improvement. In these roles, she co-authored the method validation plan for the first WGS-based method of bacterial identification, Average Nucleotide Identity (ANI), to receive approval for CLIA-regulated testing at the CDC. Ms. Turnsek earned a B.S. in Biology from Georgia State University in Atlanta. During her nine years with EDLB, she has worked as a microbiologist in the National Enteric Reference and Outbreak Team where she used traditional phenotypic and molecular techniques to identify and characterize pathogens received from national and international public health laboratories. Ms. Turnsek has conducted trainings on the isolation and identification of cholera and other acute diarrheal diseases in India, Tanzania, and Cameroon. In 2015, she volunteered for the Ebola Outbreak Response Laboratory Team in Sierra Leone.

Clinical NGS Assays: Applications and Interpretation

Lora J.H. Bean, Ph.D., F.A.C.M.G., Associate Professor, Department of Human Genetics, Emory University, Senior Director, Molecular Diagnostic Laboratory, Chief Quality Officer, EGL Genetic Diagnostics LLC

Lora J. H. Bean is an Associate Professor in the Department of Human Genetics and a Director of the Emory Genetics Laboratory Molecular Diagnostic Laboratory. She earned her PhD in the Department of Human Genetics at Case Western Reserve University and completed a postdoctoral fellow at Emory University. While at Emory University she also completed clinical laboratory training and achieved certification from the American Board of Medical Genetics in Molecular Diagnostics. Dr. Bean serves as Senior Director in the Molecular Diagnostic Laboratory, EGL Genetics Diagnostics. The EGL Molecular Diagnostic Laboratory performs traditional clinical molecular testing, such as genotyping, fragment analysis and Southern blotting, but also newer techniques such as sequencing for rare diseases, next generation sequencing, gene targeted microarrays, and most recently whole exome sequencing. Dr. has an interest in the application of molecular techniques in newborn screening and was responsible for implementation and oversight for the first five years of second tier molecular testing for cystic fibrosis newborn screening in the state of Georgia.

Brady Culver, Senior Research Scientist, Research and Development, ArcherDX, Inc.

Dr. Culver earned his PhD in Molecular Biology from CU Boulder. As a postdoc at NYU, he used proteomics and genomics to elucidate the function of Huntington’s disease proteins. As an industry scientist, he invented patented methods for nucleic acid library construction and for producing siRNAs enzymatically. In his role at ArcherDX, he has lead the development of Reveal ctDNA, Variantplex Somatic, and the improvements to Fusionplex product lines.

You Li, Ph.D, Scientific Reviewer, CDRH/OIR/DMGP, FDA

You Li, Ph.D., is a geneticist leading reviews of new and upcoming technologies in the Division of Molecular Genetics and Pathology in CDRH/OIR, with a focus on NGS submissions. He is also a member of PrecisionFDA steering work group and involved in development and evaluation of NGS benchmarking software. He received Ph.D. in Human Genetics from University of Pittsburgh, followed by a post-doctoral fellowship at Children’s Hospital of Pittsburgh where he conducted research on genetic etiology of congenital heart diseases.

Wendy Rubinstein, M.D., Ph.D., Division Director, Clinical Data Management and Curation, CancerLinQ, LLC, American Society of Clinical Oncology

Dr. Wendy Rubinstein is a physician-scientist serving as Division Director of Clinical Data Management and Curation at CancerLinQ, a not-for-profit subsidiary of the American Society of Clinical Oncology (ASCO). During her five-year tenure at the National Institutes of Health, Dr. Rubinstein was Senior Scientist, Director of the NIH Genetic Testing Registry (GTR) and Chief of Medical Genetics and Human Variation at the National Center for Biotechnology Information (NCBI) where she was responsible for GTR, ClinVar, dbSNP, dbGaP, and other flagship resources. Dr. Rubinstein received the NIH Director’s Award for developing and launching GTR. She worked closely with the NIH Office of the Director and was a representative to the NIH-FDA-CMS Trilateral Genomic Medicine Workgroup and FDA-NIH Interagency Task Force on Laboratory Developed Tests. Dr. Rubinstein has 15 years’ experience directing cancer genetics programs and has been a member of three NCI-designated Comprehensive Cancer Centers. She holds dual certification in clinical genetics and clinical molecular genetics (ABMG) and is a Fellow of the American College of Medical Genetics and the American College of Physicians.

Marc S. Williams, MD, FAAP, FACMG, FACMI, Director, Genomic Medicine Institute, Geisinger Health System

Marc S. Williams, MD, FAAP, FACMG, FACMI is a clinical geneticist. He is the director of the Genomic Medicine Institute of the Geisinger Health System. He is the co-PI of the Geisinger eMERGE project and is the medical director of the whole genome sequencing clinical research project. He is site PI and leads the EHR workgroup of the NHGRI funded ClinGen project. He is on the NHGRI Genomic Medicine working group. He has participated in the Personalized Medicine Workgroup of the Department of Health and Human Services’ American Health Information Community Task Force, and was a member of the Secretary’s Advisory Committee for Genetics, Health and Society. He is a member of the EGAPP working group. He is a past member of the ACMG Board of Directors, serving as Vice-President for Clinical Genetics. He is past chair of the ACMG Committee on the Economics of Genetic Services and founded the ACMG Quality Improvement Special Interest Group. He is a member of the Scientific Advisory Board of the Clinical Pharmacogenetic Implementation Consortium and a member of the CPIC informatics committee. He recently joined the Scientific Advisory Board of the NIH Undiagnosed Diseases Project. He is boarded in clinical informatics and is a member of the AMIA genomics and translational bioinformatics workgroup and on the Clinical Decision Support Consortium. He has authored over 125 articles on a variety of topics including the economic evaluation and value of genetic services, implementation of genomic medicine and the use of informatics to facilitate genomic medicine.

Chen-Hsiung Yeh, Ph.D., CSO, CirculoGene Theranostics

Dr. Chen-Hsiung Yeh received his Ph.D. in Microbiology and Molecular Genetics from Rutgers University, and completed his post-doctoral training at Washington University School of Medicine at St. Louis. He has over 20 years of experience in clinical diagnostics industries. He has held senior management positions in various companies including Vice President of Molecular Testing at Atherotech Diagnostics Lab; Scientific Director at Quest Diagnostics; and Principal Investigator at Pfizer.

Shanrong Zhao, Ph.D., Director, Precision Medicine, Pfizer Worldwide Research & Development

Shanrong is Director, Computational Biology and Bioinformatics at Pfizer Inc. (https://www.linkedin.com/in/shanrong-zhao-79244915). More than 20 years of experience in computer science, statistics, genetics and computational biology. Deep scientific knowledge in immunology, autoimmune disease, antibody design and biomarker discovery. Have a demonstrated track of records in scientific initiative, innovation, and leadership, including 4 patents, over 20 peer-reviewed publications, and 20 invited talks at international meetings. A recognized pioneer in the field of RNA-seq, big data analysis and cloud computing. Enthusiastic about using NGS technology, computational approaches and informatics systems to drive drug discovery and biological research.

Clinical Application of Cell-Free DNA

Jim Almas, M.D., Medical Officer, Center for Clinical Standards and Quality, Coverage and Analysis Group, Centers for Medicare & Medicaid Services

Dr. James Almas is a pathologist in Baltimore, MD and is affiliated with St. Dominic Hospital. He received his medical degree from Columbia University College of Physicians & Surgeons and has been in practice for more than 20 years.

Hector A. Alvarez, M.D., Ph.D., Scientific Manager, System Biology & Personalized Medicine, Sheikh Ahmed Bin Zayed Al Nahyan Center for Pancreatic Cancer Research, The University of Texas MD Anderson Cancer Center

No bio available.

Karen E. Bijwaard, Scientific Master Reviewer, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, U.S. Food and Drug Administration

Karen Bijwaard, MS, RAC, MB(ASCP), joined the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR) in April 2005 as a Scientific Reviewer in the Division of Immunology and Hematology Device evaluation (DIHD) and then in the Division of Molecular Genetics and Pathology (DMGP) when it was created in April 2014. In her current position, she reviews submissions for molecular pathology, genetics, instrumentation, software, and companion diagnostic In Vitro Devices (IVDs) and diagnostic software/instrumentation. She is the DMGP product specialist for cell-free/circulating-tumor DNA assays and medical device instrumentation and software. She is a consultant for other divisions in OIR and the Centers for Biologics and Drugs. She is a member in a number of genetics/genomics committees and working groups in FDA. Ms. Bijwaard is certified by ASCP as Technologist in Molecular Biology and received her Regulatory Affairs Certification from the Regulatory Affairs Professional Society in 2009. She has been an active member of the Assoc. for Molecular Pathology since 1996. In addition, she is active in CLSI and has served as a Subcommittee member and Advisor on several new and revised guidelines. Ms. Bijwaard received her undergraduate degrees in Animal Science and Biology from VA Tech in Blacksburg, VA and her Master’s Degree in Pathology from Georgetown University in Washington, DC. Prior to joining OIR, she has extensive laboratory experiences in the area of molecular diagnostics. Previously she has worked as a medical technologist in the Molecular Diagnostics Laboratory (MDL) in the Dept. of Pathology at Georgetown University. In 1996, she joined the MDL at the Armed Forces Institute of Pathology as a medical technologist where she continued to perform and created new molecular assays until 2003, after which she worked in the Laboratory of Immunology at NIH/NIAID.

Eli Casdin, Managing Member, Casdin Capital

Eli has spent the past 13 years analyzing and investing in disruptive technologies and business models in Life Sciences and Healthcare. Eli holds a BS from Columbia University and MBA from Columbia Business School.

Mary Nesline, Senior, Vice President, Knowledge Informatics, OmniSeq Inc.

Mary Nesline is SVP of Knowledge Informatics at OmniSeq, a precision medicine molecular diagnostics company in Buffalo, NY. Mary leads clinical evidence development and management, as well as integration with bioinformatics and information technology for product design and delivery. Prior to joining Omniseq, Mary played several roles at Roswell Park Cancer Institute (RPCI), including Director of Clinical Support Informatics for the Center for Personalized Medicine, and Co-Director of the Institute’s Data Bank and BioRepository and collaborating to develop shared translational research resources and infrastructure from the ground up. Mary earned a Master’s of Science degree in Epidemiology from the State University of New York at Buffalo, where she focused on implementing novel primary care service delivery and reimbursement models for vulnerable populations in the Department of Family Medicine.

Ryan B. Corcoran, M.D., Ph.D., Translational Research Director, Tucker Gosnell Center for Gastrointestinal Cancers, Massachusetts General Hospital Cancer Center

Ryan B. Corcoran, M.D., Ph.D. is the Director of the Gastrointestinal Cancer Center Program and the Massachusetts General Hospital Cancer Center. His laboratory focuses on understanding the molecular basis of therapeutic resistance in order to devise novel strategies to improve patient outcomes.

Brady Culver, Senior Research Scientist, Research and Development, ArcherDX, Inc.

He is an optimistic and enthusiastic molecular biologist with expertise in product development, NGS, functional genomics, and nucleic acid engineering. His ideas and efforts have led to four patent applications at two companies in unrelated areas, and he has launched more than 10 products as an R&D scientist in biotechnology.

Luis A. Diaz, M.D., Head, Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center

Dr. Diaz is an internationally recognized physician-scientist with a special interest in cancer genetics and immuno-oncology. His work has involved the clinical development of tumor-derived DNA as a biomarker for cancer screening, early detection, monitoring, and the measurement of early residual disease. He is currently the Head of the Division of Solid Tumor Oncology in Memorial Sloan Kettering’s Department of Medicine. He cares for patients with advanced colon cancer and pancreatic cancer and a researcher applying cancer genetics to find new ways to diagnose and treat the disease.

Maximilian Diehn, M.D., Ph.D., Assistant Professor, Radiation Oncology, Stanford Cancer Institute, Institute for Stem Cell Biology & Regenerative Medicine, Stanford University

Max Diehn, M.D., Ph.D. is an Assistant Professor of Radiation Oncology at Stanford University. He has co-appointments in the Stanford Cancer Institute and Institute for Stem Cell Biology and Regenerative Medicine. Dr. Diehn trained at Harvard University and Stanford University and has a background in genomics and stem cell biology. He is also a board-certified Radiation Oncologist and specializes in treatment of lung cancer. Dr. Diehn’s research programs spans basic, translational, and clinical studies. He has made significant contributions in number of areas, including in cancer stem cell biology and cancer genomics. His group recently developed a next generation sequencing-based method for detection of circulating tumor DNA called CAPP-Seq. Further development and clinical application of this approach are major ongoing research efforts in his laboratory.

Joseph V. Ferrara, President, Boston Healthcare Associates

Mr. Ferrara has over 18 years of experience in life sciences consulting, working with biopharmaceutical, medical device, diagnostics, and healthcare IT clients in market and business development strategy. Mr. Ferrara has expertise in the value of medical technology innovation, with a focus on pharmacogenomics, specialty pharmaceuticals, and novel therapeutic devices.

John L. Fox, M.D., MHA, Associate Chief Medical Officer and Vice President of Medical Affairs, Priority Health and Associate Professor, Michigan State University College of Human Medicine

John Fox, M.D., MHA, is the Senior Medical Director and Vice President of Medical Affairs for Priority Health in Grand Rapids, Michigan. He earned his BS in chemistry and biochemistry in 1983 from the University of Illinois in Chicago, and his MHA in 2000 from the University of Wisconsin, Department of Preventative Medicine. His M.D. was completed in 1989 from Johns Hopkins University School of Medicine in Baltimore, MD, where he also completed his internship and residency in pediatrics. Furthermore, he conducted his fellowship at the Epidemic Intelligence Service at the CDC. His current interests include the use of cost-effectiveness and number-needed-to-treat analyses in assessing the benefits of medical services and the effect of pay for performance programs on health outcomes.

David R. Gandara, M.D., Director, Thoracic Oncology Program; Professor and Senior Advisor to the Director, University of California, Davis Comprehensive Cancer Center

Dr. Gandara’s research interests focus on developmental therapeutics of new anti-cancer agents as well as preclinical modeling and clinical research in lung cancer. He is the principal investigator on an Early Therapeutics award from the National Cancer Institute (NCI), where he leads an interdisciplinary team of clinical oncologists, pharmacologists, molecular biologists and statisticians in developing new anti-cancer agents in a variety of novel drug classes. He also leads a multi-specialty team in the Southwest Oncology Group (SWOG), an NCI-funded national clinical research organization, in studies related to improving therapies for lung cancer and developing predictive biomarkers of therapeutic efficacy. Dr. Gandara is also the UC Davis principal investigator for a multi-institutional collaboration (iGXT: integrated Genetically-engineered mouse models, patient-derived Xenografts, and Clinical Trials) between the NCI Center for Advanced Preclinical Research (CAPR) and Jackson Laboratory, an NCI-designated basic cancer center. The goal of this iGXT project is to develop better preclinical models to optimize cancer drug development and speed the transition to personalized cancer therapy.

Filip Janku, M.D., Assistant Professor, Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center, The University of Texas

Dr. Filip Janku, M.D., Ph.D. is an Assistant Professor in the Department of Investigational Cancer Therapeutics (Phase I Program) at MD Anderson Cancer Center. Dr. Janku obtained his M.D. and Ph.D. at the Charles University Prague. He joined the Department of Investigational Cancer Therapeutics in the 2011 after completion of the fellowship at the same department. Dr. Janku is a principal investigator for numerous Phase I, most of which involve novel, targeted agents, many of those being novel first-in-human studies. Dr. Janku received multiple awards for his research efforts, including Sidney Kimmel Scholar award, several ASCO Merit Awards as well as an American Association for Cancer Research Scholar-in-Training Award. Dr. Janku has published over 140 articles in peer-reviewed journals. Dr. Janku's academic research interests focus on proof-of-concept clinical trials that possess a pivotal correlative component especially those involving liquid biopsies, molecular profiling of cell-free DNA, the PI3K/AKT/mTOR pathway and therapeutic use of oncolytic bacteria.

Winston Koh, Ph.D., Research Fellow, Molecular Engineering Lab, Agency of Science, Technology & Research (A*STAR)

Dr. Winston Koh gained his Ph.D. from Stanford University, after studying Bioengineering at Imperial College London. After his Ph.D., he joined a startup, Molecular Stethoscope (San Diego), developing cfRNA-based assays for neurodegenerative diseases. He’s currently based in Singapore, exploring wider clinical applications for nucleic acid based molecular diagnostics. His research interests focus on adapting sequencing and nucleic acid detection technologies into platforms capable of clinically actionable measurements, in particular, the quantification of circulating nucleic acids and single cells in metabolic, aging and neurodegenerative diseases.

Scott Kopetz, M.D., Ph.D., Associate Professor, GI Medical Oncology, University of Texas MD Anderson Cancer Center

Dr. Scott Kopetz graduated Summa Cum Laude from Vanderbilt University with a bachelor’s degree in Biomedical Engineering/Electrical and received his medical degree from Johns Hopkins School of Medicine. He obtained his residency training in Internal Medicine at Duke University Medical Center, followed by a medical oncology fellowship at MD Anderson Cancer Center. Dr. Kopetz joined MD Anderson Cancer Center in 2006 as an Assistant Professor of Medicine in the Department of Gastrointestinal Medical Oncology. He subsequently completed a Ph.D. at MD Anderson in cancer biology with thesis focus on mechanisms of chemotherapy resistance in colorectal cancer. Dr. Kopetz is board-certified in Internal Medicine and in Medical Oncology. He has authored over 100 peer-reviewed articles in respected scientific journals such as Journal of Clinical Oncology, Lancet, Cancer Research, Cancer, Clinical Cancer Research, and JAMA, and is a senior editor for Clinical Cancer Research, and editorial board member on Journal of Clinical Oncology and JNCI. He is vice chair for colon cancer research in the NSABP/RTOG cooperative group, and member of the NIH Gastrointestinal Oncology Steering Committee. In addition, he was a recipient of peer-reviewed grants from American Society of Clinical Oncology and the National Institute of Health, among others. He is the principal investigator of several Phase I and II clinical trials, including of Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC) study, a novel biomarker enrichment program for colorectal cancer. His research interests include the biology of the refractory colorectal cancer and the development of novel therapeutics for molecularly distinct subsets of colorectal cancer patients.

Bob T. Li, M.D., MPH, Assistant Attending Physician and Attending Medical Oncologist, Thoracic Oncology Service, Developmental Therapeutics, Memorial Sloan Kettering Cancer Center

Bob Li, M.D. is an attending medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center (MSK), New York, NY. Bob grew up in Sydney, Australia, and obtained his medical degree from the University of New South Wales. He undertook postgraduate training in internal medicine and medical oncology under the Royal Australasian College of Physicians, before relocating to New York to complete a medical oncology advanced fellowship at MSK. He is currently a faculty lung cancer specialist and leads the thoracic liquid biopsy program at MSK.

Lisa Meier McShane, Ph.D., Chief, Biostatistics Branch, Biometric Research Program, DCTD, NIH, NCI

Dr. McShane is a Mathematical Statistician and Chief of the Biostatistics Branch in the Biometric Research Program in the Division of Cancer Treatment and Diagnosis (DCTD) at the U.S. National Cancer Institute (NCI). She advises NCI on development of tumor markers for prognosis, therapy selection, and disease monitoring. She holds a Ph.D. in Statistics from Cornell University and is a Fellow of the American Statistical Association. Her statistical research interests include biomarker-driven clinical trial design, analysis methods for high-dimensional omics data, multiple comparisons methods, surrogate endpoints, measurement error adjustment methods, and biomarker assay analytical performance assessment. She co-led efforts to develop “Reporting guidelines for tumor marker prognostic studies (REMARK)” and “Criteria for the use of omics-based predictors in clinical trials.” She is a coauthor of numerous statistical and biomedical papers and the book Statistical Design and Analysis of DNA Microarray Investigations. Dr. McShane serves on the Scientific Advisory Board for Science Translational Medicine and the Editorial Board for BMC Medicine. She has served on several American Society of Clinical Oncology panels and committees, including those that developed guidelines for HER2 and hormone receptor testing in breast cancer, EGFR mutation testing in lung cancer, and use of tumor biomarkers in early stage breast cancer. She has served as a member of the Institute of Medicine Committee for Management of the Air Force Health Study Data and Specimens, the Consensus Committee on Management of the Air Force Health Study Data and Specimens-Report to Congress, and the Committee on the State of the Science in Ovarian Cancer Research.

Stan Skrzypczak, MBA, Vice President, Corporate Development and Reimbursement, Guardant Health, Inc.

Stan has more than 25 years of global experience in both diagnostics and cancer therapeutics. He has held senior strategic commercial, reimbursement, and business development roles at Genentech, Genomic Health, and Invitae. He currently leads US reimbursement efforts and international commercial development. He holds an MBA in Marketing and a MS in Immunology and Microbiology.

Michael R. Speicher, M.D., Professor and Chairman, Institute of Human Genetics, Medical University of Graz

Michael R. Speicher, M.D. is Professor of Human Genetics and Head of the Institute of Human Genetics at the Medical University of Graz in Austria. Dr. Speicher studied computer science at the University of Dortmund (Germany) and graduated with an M.D. degree from the University of Essen (Germany). He conducted his clinical and scientific training in Human Genetics at the University of Heidelberg (Germany), at Yale University, and at the University of Munich (Germany). For many years, Dr. Speicher studied chromosome structure and morphology using various molecular cytogenetic approaches and mechanisms of chromosomal instability. His more recent research is focused on hereditary tumor syndromes, the contribution of germline and somatic genomic variants to cancer, and single cell analysis. Current research projects are directed towards methods for the non-invasive monitoring of cancer evolution by analyses of circulating tumor cells and circulating tumor DNA.

John Strickler, M.D., Assistant Professor, Medicine, Medical Oncology, Duke University Medical Center

Dr. John Strickler is an Assistant Professor of Medicine in the Division of Medical Oncology at Duke University. His clinic focuses on the treatment of gastrointestinal malignancies, with a particular emphasis on esophageal, gastric, pancreatic, and colorectal cancers. His research focuses on the design and execution of first-in-human and investigator-initiated clinical trials with correlative studies. He has a particular interest in non-invasive testing to identify and treat genomic drivers of treatment resistance. He has recently served on the ASCO Guidelines Committee for Locally Advanced Pancreatic Cancer, and he is a member of the GI Steering Committee for the Academic and Community Cancer Research United (ACCRU) clinical trial consortium.

Jeanne Tie, M.D., MBChB FRACP, Senior Research Fellow, Systems Biology and Personalised Medicine Division, Walter and Eliza Hall Institute of Medical Research

Jeanne Tie is a senior research fellow at the Walter and Eliza Hall Institute of Medical Research and a medical oncologist at the Peter MacCallum Cancer Centre. Her research interests include the clinical applications of liquid biopsies in colorectal cancer, particularly the potential clinical utility of circulating tumor DNA in early stage disease. Her recent work is selected by the American Society of Clinical Oncology as one of the year’s major achievements in clinical cancer research and care.

Jon Wetzel, COO, TriMetis Life Sciences

Jon Wetzel has over 21 years of experience in the life sciences and 17 years of management experience in start-up biotech companies. Prior to co-founding FoundationBio which is now part of TriMetis, he served in academia and senior roles in industry: University of Michigan, UCLA, Genelogic, Rosetta Inpharmatics, Asterand and AdeptBio. He has Certifications from the University of Michigan for Lean and Six Sigma and is a Certified Six Sigma Black Belt. Jon is on several publications and is the co-inventor on and patent holder of several products.

Companion and Complementary Diagnostics in Immuno-Oncology

Kenneth Emancipator, M.D., Executive Medical Director and Head of Companion Diagnostics, Translational Medicine, Merck

Dr. Emancipator led the Merck team which partnered with Agilent Technologies (Dako) to develop the first FDA-approved companion diagnostic in cancer immunotherapy, the 22C3 PD-L1 immunohistochemistry test, which later enabled Keytruda® (pembrolizumab) to become the first immunotherapy to be approved for first-line treatment of non-small cell lung cancer. He was one of six members of the Keytruda Team to receive the 2015 PhRMA Research and Hope Award for Biopharmaceutical Industry Research on behalf of Merck. He has held positions at the US National Institutes of Health, the US Food and Drug Administration, Cornell University Medical College, Beth Israel Medical Center (NY), Bayer Healthcare, Siemens Healthcare, and Abbott Molecular. He is a former officer of the American Society for Clinical Pathology, and is a regular reviewer for the American Journal of Clinical Pathology. His credits include more than 100 papers and abstracts, and more than 100 extramural presentations

Alan L. Epstein, M.D., Ph.D., Professor, University of Southern California Keck School of Medicine

Fred R. Hirsch, M.D., Ph.D., Professor of Medicine and Pathology, Pia and Fred R. Hirsch Endowed Chair, University of Colorado Cancer Center; CEO, International Association for the Study of Lung Cancer (IASLC)

Fred R. Hirsch, MD, PhD is Professor of Medicine and Pathology at the University of Colorado School of Medicine in Denver, U.S.A. His research interests which have spanned more than 25 years include translational research, targeted therapies and early detection of lung cancer. He is also studying biomarkers related to molecular targeted therapies in order to understand the mechanisms of action and resistance of these new therapies, and to be able to select the patients who will benefit from such treatment. The biomarker studies relate to the development of molecular targeted therapies for chemoprevention and treatment of lung cancer including studies on lung cancer cell lines and tumor tissue from clinical cohorts. Within the last years focus has been on identifying biomarkers, which can be used to select lung cancer patients to EGFR tyrosine kinase inhibitors and other EGFR inhibitors. Dr. Hirsch’s laboratory is currently studying biomarkers in multiple clinical trials performed in the US and Europe both in lung and head and neck cancer. Dr. Hirsch has served on NCI’s Steering Committee for Thoracic Malignancies Program (CTEP) and is also Co-Chair for Southwest Oncology Group’s (SWOG) Lung Cancer Translational Research Committee. Dr. Hirsch serves as Associate Director for the University of Colorado Cancer Center. In November 2013, Dr. Hirsch became the CEO of the International Association for the Study of Lung Cancer (IASLC), the only global organization dedicated to the study of lung cancer. The IASLC’s membership includes 6,000 lung cancer specialists in over 100 countries. Dr. Hirsch has published more than 300 peer-reviewed scientific articles.

David L. Rimm, M.D., Ph.D., Professor of Pathology and Medical Oncology, Pathology, Yale University School of Medicine

Dr. David Rimm is a Professor in the Departments of Pathology and Medicine (Oncology) at the Yale University School of Medicine. He is the Director of Yale Pathology Tissue Services. He completed an MD-PhD at Johns Hopkins University Medical School followed by a Pathology Residency at Yale and a Cytopathology Fellowship at the Medical College of Virginia. His research lab group focuses on quantitative pathology using the AQUA® technology invented in his lab with projects related to predicting response to therapy or recurrence in cancer. The work is supported by grants from the NIH, BCRF, and sponsored research agreements from biopharma. He also serves on the CAP Molecular Oncology committee and multiple scientific advisory boards for biotech and pharma. He is an author of over 300 peer-reviewed papers and 8 patents. He was a scientific co-founder of HistoRx, a digital pathology company (sold to Genoptix in 2012), Metamark Genetics, and Pixel Gear.

Kurt A. Schalper, Ph.D., Assistant Professor, Pathology and Medicine (Medical Oncology), Yale University

I trained as cell biologist and surgical pathologist. My major interest includes molecular diagnostics and measurement of tissue biomarkers for anti-cancer immunotherapy. Currently, I am an Assistant Professor of Pathology at Yale University and director of the Translational Immuno-oncology Laboratory at the Yale Cancer Center. This lab is devoted to produce and support high quality translational research in immuno-oncology through standardized analyses of biomarkers and cross-integration with other Yale resources. We aim to open new opportunities for biomarker discovery, identification of targets and patient selection for novel immunostimulatory therapies.

Dan Snyder, President & CEO, MolecularMD

Janaki Veeraraghavan, Senior Scientific Reviewer, Division of Molecular Genetics and Pahtology, CDRH/FDA

I graduated from University of Texas Health Science Center at San Antonio with her Ph.D. Degree in Biochemistry where my thesis research investigated the role of growth factors and the impact of MMR mutation to cell cycle progression in colon carcinoma. As a post-doctoral fellow at University of Rochester my research identified biochemistry of sequence expansion caused by DNA replication errors at repeat regions. My career spans a stint at a biotech startup in upstate New York where I was involved in the development of an antibody therapeutic targeting autoimmune diseases and cancer immunotherapy and particularly in identification and development of predictive biomarkers. I left the private sector about 3 year ago for my current position as a senior Reviewer at the FDA. I have been involved in the review of companion and complementary diagnostic devices for oncology indications and development of guidelines tissue agnostic device development and review of immunohistochemistry devices.

Ignacio I. Wistuba, M.D., Translational Molecular Pathology Organization, UT MD Anderson Cancer Center

Ignacio I. Wistuba, M.D., is Professor and Chair of the Department of Translational Molecular Pathology, with a joint appointment in Thoracic/Head and Neck Medical Oncology at M.D. Anderson Cancer Center in Houston, TX. He is director of the MD Anderson CCSG-funded Institutional Tissue Bank (ITB) and Research Histology Cores, director of the ECOG-ACRIN Central Biorepository and Pathology Facility, and co-leader of the MD Anderson APOLLO Moon Shot Platform. He is a surgical and molecular pathology specialist with a strong record of scientific achievement in lung cancer with over 450 peer-reviewed papers and several book chapters. His research interests include the elucidation of the molecular abnormalities involved in the pathogenesis and progression of lung cancer, and the identification of novel molecular targets and validation of biomarkers for targeted therapy. At MD Anderson Cancer Center, Dr. Wistuba oversees biomarker studies for lung cancer and other solid tumors therapeutic clinical trials, particularly on immunotherapy. Additionally, he currently serves as the pathologist of the Lung Cancer Committee of SWOG, the Lung Cancer Mutation Consortium (LCMC), and member of the Pathology Panel of the International Association for the Study of Lung Cancer (IASLC). He serves as senior editor of Cancer Prevention Research (AACR) and Annals of Oncology (ESMO), and is member of editorial board of Clinical Cancer Research and other journals.

Commercialization of Molecular Diagnostics

Taher Abbasi, Co-Founder, Chief Design Officer, Cellworks Group Inc.

Taher Abbasi is Co-Founder and Chief Design Officer of Cellworks Group. His specialization is electronic automation engineering applied to life sciences industry and semiconductor verticals. He has been part of core founding team involved in establishing the different components of an automated precision medicine bio-simulation enabled workflow with retrospective and prospective clinical trials for validating the predictions. Taher holds a M.S. in Computer Engineering from California State University, Northridge, MBA from University of California, Los Angeles and National University of Singapore.

Jim Almas, M.D., Medical Officer, Center for Clinical Standards and Quality, Coverage and Analysis Group, Centers for Medicare & Medicaid Services

Eli Casdin, Managing Member, Casdin Capital

David Cavanaugh, Partner, DeciBio Consulting

David Cavanaugh is a partner at DeciBio with over 15 years of combined experience in life science business consulting and academic and corporate life science research and development. David has extensive experience assisting medical device clients with market assessments, opportunity identification, product/franchise expansion strategies, growth strategy development, and new product developments. Prior to DeciBio, David worked for six years as a Senior Manager at L.E.K. Consulting where he managed multiple ongoing lifescience engagements at a time. Prior to that, David worked for seven years as a computational biologist at leading organizations, including Genentech and GlaxoSmithKline. David received his MBA from the Kellogg School of Management at Northwestern University with a focus in international strategy, biotechnology and healthcare and his BS in Chemical Engineering from UVA.

Robert Cook-Deegan, M.D., Professor, School for the Future of Innovation in Society, Consortium for Science, Policy & Outcomes, Arizona State University

Robert Cook-Deegan is a professor, School for the Future of Innovation in Society, and Consortium for Science, Policy & Outcomes at Arizona State University. He founded and directed Duke’s Center for Genome Ethics, Law & Policy 2002- 2012, and Duke-in-Washington through June 2016. Before Duke: National Academies of Science, Engineering and Medicine 1991-2002, National Center for Human Genome Research (NIH) 1989-1990, and congressional Office of Technology Assessment 1982-1988. He received his BA in chemistry (magna cum laude) at Harvard in 1975 and M.D. at the University of Colorado in 1979. He has also authored The Gene Wars: Science, Politics, and the Human Genome and over 250 other publications.

Brady Culver, Senior Research Scientist, Research and Development, ArcherDX, Inc.

Brady Davis, Vice President, Strategy & Marketing, DNAnexus

Brady has over 15 years’ experience as an innovator and leader in the life sciences space. Currently, he heads strategy, market development, and product marketing for DNAnexus. He leads the product marketing team and works with the commercial and product development leads to accelerate new market opportunities. Brady is also responsible for building strategic partnerships with technology and services based organizations, and as a member of the Executive Team, is responsible for helping to set corporate strategy.

Dwight Denham, MBA, Vice President, Global Health Economics & Reimbursement/Market Access Danaher Corporation, Life Science & Diagnostics Segment

Mr. Denham leads the Danaher Diagnostics & Life Sciences Global Health Economics & Reimbursement Team. His group supports multiple operating companies under the Danaher Diagnostics and Life Sciences segment in their global market access planning and implementation. A frequent speaker on the value of Clinical Lab Diagnostics, Mr. Denham and his group, are active in global health economic study planning, design and execution, plus healthcare payment policy surveillance, influence, and interpretation. Mr. Denham has previously led teams for clinical research focused on registration and pre-market commercialization studies, plus health policy teams focused on evidence development for medical decision-making. He also has global product management, marketing, and sales experience introducing new products to multiple stakeholders in both commercial and government sectors.

Rahul K. Dhanda, MBA, Senior Vice President, Corp Development, T2 Biosystems Inc

Rahul Dhanda is the Senior Vice President of Corporate Development since February 2016. He joined T2 Biosystems in January 2008 and has held several leadership roles including Vice President of Marketing since 2010. Prior to joining T2 Biosystems, Rahul worked in marketing at Boston Scientific’s Urology division, where he led the team responsible for the Access, Visualization and Laser Lithotripsy franchises, representing roughly $100 million in annual revenue. Prior to Boston Scientific, Rahul worked in business development at Interleukin Genetics, where he helped negotiate the firm’s acquisition by Alticor, Inc. as well as multiple other deals. Rahul earned his MBA from MIT’s Sloan School of Management and his BA from Wesleyan University. He is a former committee member of the AAAS Committee on Scientific Freedom and Responsibility. Rahul is the author of several publications, an inventor on numerous patents and applications, and has authored the first book to address the crossroads between industry and bioethics/public policy, entitled Guiding Icarus: Merging Bioethics with Corporate Interests.

Andrew C. Fish, J.D., Chief Strategy Officer, AdvaMed; Executive Director, AdvaMedDx

As chief strategy officer, Mr. Fish leads AdvaMed's strategic planning, manages global, regulatory, and payment departments, and coordinates the development and operations of AdvaMed’s membership divisions and sectors. Prior to joining AdvaMedDx, Mr. Fish was Senior Vice President of Legal and Government Affairs, General Counsel, and Secretary for the Consumer Healthcare Products Association (CHPA), representing manufacturers of non-prescription medicines. Mr. Fish also led the American Cancer Society’s federal lobbying team as the Senior Director of Federal Government Relations. He also served in the Senate-confirmed post of Assistant Secretary of Agriculture for Congressional and Intergovernmental Affairs. Prior to that position, he worked twice for the U.S. Senate Agriculture Committee, first as a professional staff member and later as deputy chief counsel. Mr. Fish is a graduate of Yale University and Stanford Law School.

John L. Fox, M.D., MHA, Associate Chief Medical Officer and Vice President of Medical Affairs, Priority Health and Associate Professor, Michigan State University College of Human Medicine

David R. Gandara, M.D., Director, Thoracic Oncology Program; Professor and Senior Advisor to the Director, University of California, Davis Comprehensive Cancer Center

Harry Glorikian, MBA, Healthcare Consultant

Mr. Glorikian has more than 20 years of experience in the health care and life science industries. He has deep commercial background in diagnostics, molecular biology, proteomics, cellular biology and biodefense. His unique understanding of technologies, operations and strategy from both customer and industry player perspectives has shaped a sophisticated framework and proprietary analytic tools. He holds a Bachelor's Degree in Business Administration from Boston University, a Masters of Business Administration from the Boston University, and a BA in General Biology from San Francisco State University.

Manuel J. Glynias, President & CEO, GenomOncology LLC

Mr. Glynias is a serial entrepreneur with over 25 years of experience in bioinformatics. Immediately prior to GenomOncology, Manuel was a partner at Rosetta, a leading interactive marketing agency, where he helped develop big data solutions for ecommerce clients. In the late 90s, Manuel was the founder and CEO of NetGenics, a venture-backed provider of discovery informatics to the biopharmaceutical industry and academic research centers. He also developed a number of other commercial software platforms including MacGene, Gene Works, and Primer Express. Manuel has an AB in Biochemistry and Molecular Biology from Harvard College.

Kimberly Hanson, M.D., MHS, Associate Professor, Infectious Disease, University of Utah School of Medicine

Kimberly Hanson, MD, MHS is a board-certified physician in Adult Infectious Diseases and Medical Microbiology. She has specialized expertise in the diagnosis and management of opportunistic viral, fungal and mycobacterial diseases. Her primary clinical focus is transplant and cancer chemotherapy-related infections.

David R. Hillyard, M.D., Professor, Pathology, University of Utah; Director, Molecular Infectious Disease Testing, Arup Laboratories

Dr. Hillyard is a professor of pathology at the University of Utah School of Medicine. Dr. Hillyard received his M.D. from the Columbia University College of Physicians and Surgeons. His training was in anatomic and clinical pathology, with fellowships in medical microbiology and microbial genetics.

Gabriela Lavezzari, Ph.D., MBA, Senior Vice President, Business Development, Biocerna

Gabriela Lavezzari, Ph.D., MBA is the Senior Vice President of Business Development at Biocerna, an innovative company with the unique mission of making personalized medicine accessible and affordable for patients and providers. Prior to joining Biocerna in April of 2017, Dr. Lavezzari was a Research Director at the Duke-Robert J. Margolis Center for Health Policy. There she led the development of new evidence-based policies designed to shift the current payment models for innovative medical products from fee-for-service (FFS) to value-based. Dr. Lavezzari has dedicated her career to advancing the field of personalized medicine by addressing the scientific, regulatory and reimbursement challenges that hinder patients’ access to innovative medical products. By combining her experience working at PhRMA, the leading pharmaceutical trade association working as the Assistant Vice President, Science & Regulatory Affairs and as Director of Personalized Medicine, Development, at Express Scripts (previously Medco Health Solutions), the largest pharmaceutical benefit manager, Dr. Lavezzari has been focusing on tackling the current gaps in the healthcare space by developing novel approaches to improve patient outcomes while lowering the overall healthcare costs. Dr. Lavezzari received her Ph.D. in Biological Sciences from University of Milano (Italy), and received her MBA from the New York Institute of Technology (NYIT, NY).

Matt Pearce, Ph.D., President, Medtechtomarket Ltd.

Dr Matt Pearce is an experienced Executive with an extensive track record within the medical diagnostics and instrumentation, biotechnology and FMCG sectors. Focused on delivering business improvement, enhancing product performance and new technology development. He has considerable commercial, operational and scientific experience throughout USA, Asia, LATAM, and Europe.

Scott Pohlman, Associate Director Outcomes Research, Hologic

No bio available

Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates

Bruce Quinn, M.D., Ph.D. is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. Dr. Quinn has worked in academic medicine, accenture business strategies, and for the Medicare program. He received his M.D. and Ph.D. degrees at Stanford University, did his post-doc at MIT, his residency at UCLA, and his MBA at Kellogg Graduate School of Management.

Greg Richard, Senior Vice President, Interpace Diagnostics

Greg Richard has worked in the diagnostics business for over 20 years focused primarily on Sales and Reimbursement. He served as the VP of Managed Care at Quest Diagnostics and the Sales Officer for the Northeast Division for LabCorp. He has both domestic and international experience. In addition to working for the large, national lab companies, Greg has worked for start-up molecular diagnostics companies including Signal Genetics and Interpace, where he launched numerous new products, primarily focused in cancer.

Stan Skrzypczak, MBA, Vice President, Corporate Development and Reimbursement, Guardant Health, Inc.

Gregory A. Storch, M.D., Ruth L. Siteman Professor, Pediatrics; Professor, Medicine and Molecular Microbiology; Chief, Division of Pediatric Laboratory Medicine; Medical Director, Clinical Laboratories, St. Louis Children’s Hospital; Medical Director, Project ARK (AIDS Resources and Knowledge), Washington University School of Medicine

Dr. Storch is the Ruth L. Siteman Professor of Pediatrics and Professor of Medicine and of Molecular Microbiology at Washington University School of Medicine, Director of the Division of Pediatric Laboratory Medicine, Medical Director of Clinical Laboratories at St. Louis Children’s Hospital, and Medical Director of Project ARK, which provides medical and support services for children, youth, women, and families affected by HIV in the St. Louis region. He received his AB degree from Harvard College and his M.D. from NYU School of Medicine. He completed internship and residency in internal medicine at the Jewish Hospital of St. Louis, was an Epidemic Intelligence Service Officer for the Centers for Disease Control in the Louisiana Department of Health in New Orleans, and an infectious disease fellow at Washington University. He joined the Washington University faculty in 1981. Dr. Storch is active in national organizations, currently serving as President of the Pan-American Society for Clinical Virology, Chair of the Finance Committee of the Pediatric Infectious Diseases Society, and member of the Diagnostics Task Force of the Infectious Diseases Society of America. He is also an Associate Editor of the Journal of the Pediatric Infectious Diseases Society. Dr. Storch’s research interests are in molecular diagnosis of infectious diseases and infectious disease genomics. He is co-leader of the Microbial Genomics Unit of the Washington University Department of Pediatrics. Dr. Storch is a physician specializing in pediatric infectious diseases. He currently serves as Director of the Division of Pediatric Laboratory Medicine at Washington University School of Medicine and Medical Director of Clinical Laboratories at St. Louis Children’s Hospital. He has a long-standing interest in the molecular diagnosis of viral infections and currently co-direct the Microbial Genomics Unit in the Department of Pediatrics. Working closely with the McDonnell Genome Institute, we are currently conducting studies in several areas of infectious disease genomics, including studies of the human virome, applications of next generation sequencing for the diagnosis of infectious diseases, and studies of the human transcriptomic response to augment the diagnosis of infectious diseases.

Gregory J. Tsongalis, Ph.D., HCLD, CC, Professor, Pathology; Director, Laboratory for Clinical Genomics and Advanced Technology (CGAT), Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center; The Audrey and Theodor Geisel School of Medicine, Dartmouth College

Greg Tsongalis is the Director of the Laboratory for Clinical Genomics and Advanced Technology (CGAT) at the Dartmouth-Hitchcock Medical Center and Norris Cotton Cancer Center in Lebanon, NH and a Professor of Pathology at the Geisel School of Medicine at Dartmouth in Hanover, NH. His area of expertise is in clinical molecular diagnostic applications. His research interests are in the pathogenesis of human cancers, personalized medicine and disruptive technologies. He has authored/edited ten textbooks in the field of molecular pathology, published more than 200 peer-reviewed manuscripts, and has been an invited speaker at both national and international meetings. He has served on numerous committees of the AACC, ASIP, and AMP where he is a past President and currently serves on the FASEB board of directors. He is on the editorial board of 8 journals including Clinical Chemistry and the Journal of Molecular Diagnostics. He also serves on numerous corporate scientific advisory boards.

Sanjay Udoshi, M.D.

Sanjay Udoshi is a Physician Executive at Syapse, a market leader in precision oncology solutions. As Physician Executive, Sanjay helps leading health systems and cancer centers to implement and scale precision oncology programs. Sanjay brings 18 years of experience in healthcare policy consulting, contributing to state and federal legislation on clinical decision support systems and meaningful use. Sanjay was the Physician Architect for Clinical Analytics at Oracle Corporation‘s Health Sciences Global Business Unit, leading product development, strategy and business development. Previously, Sanjay completed his Fellowship in Clinical Re-engineering and Transformation at Geisinger Innovation before being made system-wide Physician Lead for Clinical Analytics at Geisinger Health System. Sanjay received an M.D. from Jawaharlal Nehru Medical University and a B.S. from the University of Pennsylvania.

Microfluidics and Lab-on-a-Chip Devices for POCT

Mario Cabodi, Ph.D., Research Assistant Professor, Boston University

Dr. Mario Cabodi is a Research Assistant Professor in the Biomedical Engineering Department of Boston University. He received an MSci degree in Physics from Imperial College (London) and a Ph.D. in Physics from Cornell University, where he was also a Postdoctoral Research Associate in Chemical Engineering. At Cornell, Dr. Cabodi used micro- and nano-fluidics for analytical separations of biomolecules, and later developed microfluidic techniques for tissue engineering applications. He joined Boston University in 2006 as Deputy Director of the Center for Nanoscience and Nanobiotechnology, and in 2008 joined the research faculty as Research Assistant Professor. At Boston University, he is applying his expertise in nanofabrication to interdisciplinary projects, such as: sample concentration methods for biosensors and point-of-care diagnostics, microfluidics for ultrasound contrast agents, and microfabrication in hydrogels for cancer metastasis models. He has also developed and taught courses in Nanomedicine and Device Design.

Steve Crouse, Chief Commercial Officer, Vortex Biosciences, Inc.

Steve Crouse is the Chief Commercial Officer, responsible for all commercial operations at Vortex Biosciences including strategy development, sales, marketing and support. Steve is a seasoned executive with >15 years of experience leading marketing and sales organizations in Life Science and Biotechnology companies. Most recently, Steve was the SVP of Sales and Marketing at Freeslate, Inc., leading global commercial operations. Steve helped transition the Freeslate business model from a custom automation business to a successful life science product business that was ultimately acquired by Unchained Labs in February 2016. Prior to joining Freeslate, Steve held several marketing, sales, and R&D leadership roles with Bio-Rad Laboratories and Life Technologies (now ThermoFisher). In these roles he led strategic planning and product development teams, was responsible for OEM and Out-licensing sales, and ran operations for a new R&D Center in Shanghai, China. He has a MBA from the Marshall School of Business at the University of Southern California and a M.S. in Biochemistry from Georgetown University.

Don L. DeVoe, Ph.D., Professor, Department of Mechanical Engineering, University of Maryland, College Park

Don L. DeVoe is a Professor of Mechanical Engineering at the University of Maryland, College Park, with affiliate appointments in the Department of Bioengineering and Department of Chemical and Biomolecular Engineering. He received his Ph.D. degree in Mechanical Engineering from the University of California, Berkeley in 1997 with a focus on microsystems technology. Dr. DeVoe’s current research interests include MEMS and microfluidics, with an emphasis on the development of disposable technologies for diagnostics, bioanalysis, and nanomedicine development. He is a recipient of the University System of Maryland Regents Award for Research, was named a Kavli Fellow of the National Academy of Sciences, and was recognized with the Presidential Early Career Award for Scientists and Engineers from the National Science Foundation for advances in microsystems technology.

Ellis Jacobs, Ph.D., DABCC, FACB, Director, Scientific Affairs, Clinical Affairs, Alere, Inc

Dr. Jacobs is Director of Scientific Affairs at Alere and is an Adjunct Associate Professor of Pathology at the Mount Sinai School of Medicine in New York City. He received his B.S. degree in Chemistry and Natural Sciences from Muhlenberg College in Allentown, PA , obtained a Ph.D. in Biochemistry from the University of South Carolina and them did postdoctoral training in Clinical Chemistry & Toxicology at the University of North Carolina, Chapel Hill. Dr. Jacobs was a laboratory director at The Mount Sinai Hospital, Bellevue Medical Center and New York University for over 25 years and has extensive experience with POCT, critical care testing, laboratory consolidation and automation, computerization and automatic result reporting, and planning and performance of clinical trials for various main laboratory and POCT systems. He has over 60 peer reviewed publications and textbook chapters and was the principal investigator on several beta site studies for various POCT analytical systems. Dr. Jacobs has been involved in establishing clinical diagnostic regulatory and accreditation standards at the local, national and international levels. He is a former director of the New York State laboratory accreditation program and is active in the Clinical and Laboratory Standards Institute. He is Chair of the CLSI Expert Panel on Point of Care Testing and was a member of the development committees for EP18 and EP23. Additionally, Dr. Jacobs is a past member, and current observer, of the US Technical Advisory Group for ISO Technical Committee 212 on Clinical Laboratory Testing and In Vitro Diagnostic Test Systems.

Changchun Liu, Ph.D., Research Assistant Professor University of Pennsylvania

Changchun Liu is a research assistant professor in Department of Mechanical Engineering and Applied Mechanics at the University of Pennsylvania. He received his PhD degree in Electronics Engineering from the Institute of Electronics, Chinese Academy of Sciences (IECAS), Beijing, China. Dr. Liu's research interests include microfluidics, BioMEMS (Biomedical MicroElectroMechanical Systems), biosensors, point-of-care (POC) diagnostics, and micro/nano fabrication technology. He has been involved the design, fabrication and integration of biomedical devices with a focus on POC diagnostic application for 14 years. He is a recipient of NIH Career Development Award (K25) and W.W. Smith Charitable Trust Award, and a co-recipient of Penn One Health Award. He published 70 peer-reviewed papers and held more than 17 patents/patent applications.

Hadi Shafiee, Ph.D., Assistant Professor of Medicine, Division of Engineering in Medicine, Division of Renal Medicine, Brigham and Women's Hospital

Dr. Shafiee’s lab aims to integrate biology/medicine with micro- and nanotechnology to develop innovative tools and solve unmet clinical problems, including applications in infectious disease diagnostics and treatment monitoring for global health, vaccine delivery, personalized cancer immunotherapy, and fertility. His lab is particularly interested in developing point-of-care diagnostics through utilizing advances in consumer electronics, nanotechnology, and optical/electrical/magnetic sensing modalities. His work has been recognized by ScienceDaily, Nature World News, Science World Report, Science Magazine, Med Device Online, Azonano, Engadget, Popular Science, Device Space, Product Design & Development, HCP Live, etc. Dr. Shafiee’s lab is funded through national, international, and institutional awards including R01 from National Institute of Allergy and Infectious Diseases, National Institute of Health, Bright Futures Prize from Brigham and Women’s Hospital, Innovation Evergreen Award from Harvard Medical School, Breakthrough Pilot Award from Harvard School of Public Health, Diagnostic Award from the American Society of Reproductive Medicine, etc.

Steven A. Soper, Ph.D., Foundation Distinguished Professor, University of Kansas

Prof. Steven A. Soper received his Ph.D. from the University of Kansas in 1989 followed by a Postdoctoral Fellowship at Los Alamos National Laboratory, where he worked on single-molecule detection for high speed sequencing of the human genome. In 1991, he joined the faculty at Louisiana State University (LSU) within the Department of Chemistry, where he filled the William H. Pryor Distinguished Chair of Chemistry. Prof. Soper also held joint appointments in the Mechanical Engineering Department and Department of Biological Sciences. While at LSU, he founded the Center of BioModular Multi-Scale Systems for Precision Medicine, which has as its primary charge to develop enabling and transformative tools for making health-related measurements from rare disease markers, such as liquid biopsy markers, with full process automation directly at the Point-of-Care. This Center has recently been awarded funding from the National Institutes of Health as part of their Biotechnology Resource Center Program (funded through the National Institute of Biomedical Imaging and Bioengineering). In 2011, Prof. Soper accepted a position within the Department of Biomedical Engineering and Department of Chemistry at the University of North Carolina, Chapel Hill.Prof. Soper is currently a Foundation Distinguished Professor in Chemistry and Mechanical Engineering at the University of Kansas, Lawrence. Prof. Soper also holds an appointment at Ulsan National Institute of Science and Technology in Ulsan, South Korea, where he is a World Class University Professor. He is also serving as a Science Advisor for a number of major worldwide companies, such as Roche Diagnostics. Prof. Soper is currently the Editor of the Americas for the Analyst and on the Editorial Board for Journal of Fluorescence and Journal of Micro- and Nanosystems. Prof. Soper is also serving as a permanent Member of the Nanotechnology study panel with the National Institutes of Health. As a result of his efforts, Prof. Soper has secured extramural funding totaling >$87M and has published over 315 manuscripts (h index = 60) and is the author of 14 patents. He is also the founder of a startup company, BioFluidica, which is marketing devices for the isolation and enumeration of circulating tumor cells. His list of awards includes Chemical Instrumentation by the American Chemical Society, the Benedetti-Pichler Award for Microchemistry, Fellow of the AAAS, Fellow of Applied Spectroscopy, Fellow of the Royal Society of Chemistry, R&D 100 Award, Distinguished Masters Award at LSU and Outstanding Scientist/Engineer in the state of Louisiana in 2001. Finally, Prof. Soper has granted 55 PhDs and 6 MS degrees to students under his mentorship. He currently heads a group of 15 researchers.

Benjamin H. Wunsch, Ph.D., Materials Science & Engineering, Surface Chemist, Staff, Nanobiotechnology, IBM Research, IBM

My background is in Materials Science and Engineering, with a B.S. from Arizona State University, and a Ph.D. from the Massachusetts Institute of Technology. My research has centered on colloidal and soft matter, working in self-assembled monolayer metal core nanocrystal chemistry, novel aerogel formation and manufacturing, and organic semiconductor thin film morphology. I joined IBM Research in 2013 as part of the Nanobiotechnology Team, working on the experimental testing of silicon fabricated nanofluidics for biotechnology applications. This work has grown to encompass study of the nanoscale flows of bio-colloids, compatibility issues between silicon and biological materials, and development of novel on-chip structures for sorting, analysis and preparation of colloids.

Rapid Critical and Urgent Care Testing

Lea Carrington, MS, MBA, MT(ASCP), Director, Division of Immunology and Hematology Devices, FDA

Lea Carrington is the Director of the Division of Immunology and Hematology Devices in FDA’s Office of In Vitro Diagnostic Device Evaluation and Radiological Health (OIR). She also served as Chief of the Hematology Branch which reviews a variety of devices and assays for hematological, coagulation and evaluation of other body fluids. Prior to joining the FDA, Ms. Carrington worked as the chief technologist in the Special Coagulation laboratory at Walter Reed Army Institute of Research. Ms. Carrington is an ASCP certified Medical Technologist and holds an MBA from Johns Hopkins University and a MS in Biomedical Technology Development and Management from Georgetown University and Virginia Tech.

Ashley Cimino-Mathews, M.D., Assistant Professor of Pathology and Oncology, The Johns Hopkins Hospital

Dr. Cimino-Mathews is an Assistant Professor of Pathology and Oncology at Johns Hopkins Hospital and is Co-Director of the Breast Pathology Consultation Service. She obtained her Bachelor of Science from Emory University, where she studied breast cancer tumor vaccine development, followed by her Doctorate of Medicine from Weill Cornell Medical College. She subsequently received her residency training in Anatomic and Clinical Pathology the Johns Hopkins Hospital, where she subspecialized in surgical and breast pathology. Dr. Cimino-Mathews focuses her research on the role of the patient’s immune response in mediating breast cancer development and metastasis, and on understanding the genetic and phenotypic differences of stromal tumors of the breast.

Peter Koerte, Ph.D., President Point of Care Diagnostics, Siemens Healthineers

Peter Koerte, president, Point of Care Diagnostics, Siemens Healthineers, was appointed to lead the POC Business Area in October 2015. Prior to his current role, he was vice president, Product Life Cycle Management, for the Point of Care Business Unit of Siemens Healthcare. He directed and was responsible for global marketing, portfolio and product management, R&D program management, business development, and R&D software development. Before joining Siemens Healthineers, he was a consultant with The Boston Consulting Group, based in Munich. He holds a PhD in international management and business strategy from Otto Beisheim School of Management (WHU) in Vallendar, Germany, and a master’s degree in industrial engineering from Karlsruhe Institute of Technology.

James H. Nichols, Ph.D., DABCC, FACB, Professor of Pathology, Microbiology and Immunology, Medical Director of Clinical Chemistry, Medical Director, Point-of-Care Testing, Vanderbilt University School of Medicine

James is a Professor of Pathology, Microbiology, and Immunology, Medical Director of Clinical Chemistry and Point-of-Care Testing at Vanderbilt University School of Medicine. Dr. Nichols received his B.A. in General Biology/Premedicine from Revelle College, University of California at San Diego. He went on to complete a Masters and Doctorate in Biochemistry from the University of Illinois, Urbana-Champaign. Jim was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, MN. He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions. Jim later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, MA and was a Professor of Pathology at Tufts University School of Medicine. Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing and toxicology.

John Toffaletti, Ph.D., Professor of Pathology, Director of Blood Gas and Clinical Pediatric Labs, Pathology, Duke University Medical Center

John Toffaletti received a BS from the University of Florida in Gainesville and followed this with training in clinical chemistry at the University of North Carolina at Chapel Hill, where he earned a PhD in Biochemistry, then completed a Postdoctoral Fellowship in Clinical Chemistry at Hartford Hospital. Since completing these programs, he has worked in the Clinical Laboratories at Duke University Medical Center since 1979, where he is now Professor of Pathology, Director of the Blood Gas Laboratory, the Clinical Pediatric Laboratory, and several Outpatient Laboratories. He is also the Chief of Clinical Chemistry at the Durham VA Medical Center. He has written or presented numerous workshops, books, study guides, chapters, and seminars on the interpretation of blood gas, cooximetry, ionized calcium, magnesium, lactate, and renal function tests. His research interests include sample collection, analysis, and clinical use of these tests.As a member of AACC, Dr Toffaletti has served as Chairman of the Contributed Papers Committee for the 1984 and 1997 Annual Meetings, Chairman of the Clinical Chemistry News Board of Editors in 1990, Chairman of the Electrolyte/Blood Gas Division in 1991 and 1992, and Chairman of the Commission on Publications in 1993. From 1999 to the present, he has served on the Board of Editors of Clinica Chimica Acta. In 2006, he chaired the Scientific Program Committee for the Critical Care and Point of Care Symposium in Quebec.

Zhen Zhao, Ph.D., DABCC, FACB, Clinical Chemist, Department of Laboratory Medicine, NIH

Dr. Zhen Zhao received her BS in biology from Xiamen University and her PhD in neurobiology and physiology from Northwestern University. She fulfilled clinical chemistry postdoctoral fellowship training at Washington University in St. Louis. She is board certified by the American Board of Clinical Chemistry and is a Fellow of the National Academy of Clinical Biochemistry. Dr. Zhao is a senior staff member of Clinical Chemistry service in the Department of Laboratory Medicine of the National Institutes of Health. She is associated director of the clinical chemistry fellowship postdoctoral training program at NIH. Her research interests are in the areas of women and children's health, biomarker discovery, and clinical applications of mass spectrometry. She is currently the Commissioner of the Commission on Accreditation in Clinical Chemistry (ComACC), Treasure of Clinical Translational Science Division of the American Association of Clinical Chemistry (AACC), Secretary of Tumor Markers and Cancer Diagnostics Division of AACC, President-elect of the North American Chinese Clinical Chemists Association; Membership committee on Academy of Clinical Laboratory Physicians and Scientists; and Expert Peer Reviewer of AACC Annual Meeting Abstracts selection. She has received several awards including NIH Clinical Center Director’s Award, AACC Capital Local Section Roe Award, NACB’s Distinguished Abstract Award, and AACC Endocrinology Division Outstanding Abstract Award.

Advances in Microbiome Diagnostics

Keith Batchelder, M.D., CEO & Founder, Genomic Healthcare Strategies

Keith Batchelder is the founder and CEO of Genomic Healthcare Strategies, a company focused on the changes in healthcare resulting from advances in molecular medicine. GHS provides strategy and implementation services for companies looking to enter or grow in the new markets emerging as result of predictive diagnostics and preventive medicine. Dr. Batchelder has long been interested in the intersection of the scientific, business and societal promises and challenges raised by personalized medicine. His area of expertise is in the analysis of new markets, channels, partners, and the new science supporting the rapidly evolving practice of medicine and wellness. During a career that has spanned medical research, clinical practice, and management in start-ups and large organizations, Dr. Batchelder focuses on the practical application of advanced healthcare innovation and its economics. He has served as chief technical officer of WorldCare International Clinical Trials, where he used biomarkers as surrogate endpoints for successful FDA approvals; as CIO of Harvard Salud Integral, where he helped to raise funding and grow a start-up HMO in Mexico City; as a principal of AMICAS Corp, where he took a web-based radiology system from concept to a venture-funded and profitable software company; and at Massachusetts General Hospital for eight years, whereas a staff member he conducted industry sponsored research in innovative drug discovery, invented novel techniques and published in peer reviewed journals. Dr. Batchelder was educated at Middlebury College, the Hahnemann University School of Medicine, received postgraduate training in Medical Informatics at The Boston VA Hospital and completed a fellowship at the Food and Drug Administration. He also holds a master’s degree in biomaterials from New York University. Dr. Batchelder writes and speaks frequently on the topic of personalized medicine (e.g., Nature Biotechnology, Scientific American conference on Targeted Medicine, Burrill & Co, LabCompete, Molecular Medicine Tri-Conference) and has organized several well attended symposia on Personalized Medicine. Dr. Batchelder, acting on his belief in the potential of personalized medicine, is one of the first ten volunteers to have their full duplex genomes sequenced and published in Harvard Genetics Professor George Church’s Personal Genome Project.

Andrea Hahn, MD, Assistant Professor, Infectious Diseases, Children’s National Health System

Andrea Hahn, MD, is an Attending in Infectious Diseases and K12 Scholar in the Omics of Lung Disease at Children’s National Medical Center in Washington, DC. She completed her pediatric residency at Nationwide Children’s Hospital in Columbus, OH in 2011 and her infectious disease and clinical pharmacology fellowships at Cincinnati Children’s Hospital Medical Center in 2014. Dr. Hahn is board certified in Pediatrics, Pediatric Infectious Diseases, and Clinical Pharmacology. She was awarded an NIH T32 training grant in Pediatric Clinical Pharmacology from 2012-2014, as well as an NIH K12 training grant in the Omics of Lung Disease in Children from 2014-2017. She has also receiving research funding from the NIH Loan Repayment Program, the Clark Charitable Trust, and the Margaret Q. Landenberger Foundation. She brings expertise in pharmacokinetic modeling of antimicrobials to Children’s National, and is currently investigating the impact of sub-therapeutic beta-lactam antibiotics on the airway microbiome in children with cystic fibrosis.

Alison Laufer Halpin, Team Lead, Metagenomics and Molecular Biology Team, Clinical and Environmental Branch, Division of Healthcare Quality Promotion, CDC

Alison Laufer Halpin has worked for the Division of Healthcare Quality Promotion since 2013. She is currently the Lead of the Metagenomics and Molecular Biology Team in the Division of Healthcare Quality Promotion, Clinical and Environmental Microbiology Branch and a Lieutenant Commander in the U.S. Public Health Service. Her team focuses on leveraging next generation sequencing technologies and bioinformatics applications to prevent and control healthcare-associated infections; specifically, outbreak investigations, surveillance for and detection of novel antibiotic resistance mechanisms, and microbiome research. From 2011 to 2013, she was an Epidemic Intelligence Service Officer in the Division of Foodborne, Waterborne, and Environmental Diseases. She received her Bachelor’s degree from the University of Connecticut and her doctorate in molecular epidemiology from Yale University.

David Haslam, M.D., Associate Professor, Pediatric Infectious Diseases, Cincinnati Children’s Hospital

A major goal of our laboratory is to determine the role of commensal microorganisms (the microbiome) in defense against infectious diseases. In particular, we are investigating the intestinal microbiome as the source for antibiotic resistant bacterial infections. Similarly, we probed the intestinal microbiome in animal and human C. difficile infections and identified commensal bacteria that confer resistance to C. difficile infection. Our laboratory developed a bioinformatics pipeline to that takes raw DNA sequencing read data all the way through taxonomic assignment and antibiotic gene detection to advanced statistical analysis. Another major focus of our group is to identify risk factors for invasive infection due to multidrug resistant bacteria. To that end, we are applying next generation sequencing and metagenomic analysis to identify changes in the microbiome that correlate with risk for invasive infection. In particular, for this application, we have the tools, software, and analytical expertise to develop this assay into a clinically actionable diagnostic test.

Lori Holtz, M.D., MSPH, Assistant Professor, Pediatrics, Washington University School of Medicine

I am a pediatric gastroenterologist at Washington University in St. Louis. Work in my lab focuses on disorders of the developing childhood gut and employs metagenomics, virology, and epidemiology to begin to define the stool virome in health and disease. My lab uses next generation sequencing to interrogate clinical specimens from healthy and diseased children to define the viruses present. This method detects both known and novel viruses in samples. Using these methods we have discovered novel astroviruses (MLB2, MLB3, VA2, VA3, VA4, and VA5) as well as novel picornaviruses (klassevirus and cosavirus E-1). We have also described the comprehensive virome in health and diarrhea. We completed a multi-site comparison of the stool viromes of children with diarrhea from geographically distinct sites and found that viromes from children in a rural resource poor setting contain more viral families per sample than viromes from a westernized urban setting. Recently we defined the gut virome (eukaryotic and phage) and bacterial microbiome of a longitudinal cohort of healthy infant twins and found that in contrast to the stable microbiome and virome observed in adults, the infant microbiome and virome is highly dynamic.

Georgios Kitsios, M.D., Ph.D., Instructor of Medicine; Post-Doctoral Scholar, Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh Medical Center

Georgios Kitsios, MD PhD is a Pulmonary and Critical Care Medicine physician and translational investigator interested in the role of the microbiome in the etiology, evolution and outcome of critical illness. He received his MD from Aristotle University of Thessaloniki in Greece in 2003 followed by his PhD in Genetic Epidemiology from the University of Thessaly awarded in 2009. Following a Post-Doctoral fellowship in Clinical and Translational Science at Tufts University in Boston, Georgios completed his residency at the Lahey Hospital & Medical Center in Burlington, MA in 2014, where he was also recognized with the awards of Resident of the Year 2014 and the Tufts School of Medicine Teaching award. He then completed his fellowship in Pulmonary and Critical Care Medicine at the University of Pittsburgh Medical Center, where he was recognized with the Fellow Teaching award in 2015 and supported by an institutional T32 training award for advancing his training in the field of the critical illness microbiome. He is currently an Instructor of Medicine at the University of Pittsburgh conducting translational research in the ICU. Georgios is utilizing his expertise in evidence synthesis and comparative effectiveness methodologies with new skills in next-generation sequencing, bioinformatics and big data analytics to study the role of the lung and gut microbiome in critically-ill patients and develop new personalized diagnostic and therapeutic interventions. He has published >50 manuscripts in high-impact journals and is currently leading efforts for deriving microbiome-based definitions of pneumonia in mechanically-ventilated patients and informing antibiotic management decisions in real-time.

Kostas Konstantinidis, Ph.D., Associate Professor, School of Civil & Environmental Engineering and School of Biological Sciences (Adjunct), Georgia Institute of Technology

Dr. Konstantinidis joined the faculty at Georgia Tech in November 2007, was tenured and promoted to Associate Professor in March 2014, and holds the Carlton S. Wilder Junior Professorship in Environmental Engineering since September of 2012. His research is at the interface of microbiology with environmental engineering and computational biology. The overarching goal of his research is to broaden our understanding of role of bacteria and archaea in ecosystem function and resilience to natural as well as anthropogenic perturbations. He is also interested in the biotechnological applications of microbial diversity in the bioremediation of environmental pollutants and the assessment of water quality. The great majority of microorganisms resists cultivation in the laboratory and thus, cannot be studied efficiently. Therefore, a major objective of Dr. Konstantinidis’ research program is to develop novel culture-independent (aka metagenomics and metatranscriptomics) approaches to study microbial communities in-situ, in both natural (e.g., terrestrial or marine) as well as human-associated systems.Dr. Konstantinidis joined the faculty at Georgia Tech in November 2007, was tenured and promoted to Associate Professor in March 2014, and holds the Carlton S. Wilder Junior Professorship in Environmental Engineering since September of 2012. His research is at the interface of microbiology with environmental engineering and computational biology. The overarching goal of his research is to broaden our understanding of role of bacteria and archaea in ecosystem function and resilience to natural as well as anthropogenic perturbations. He is also interested in the biotechnological applications of microbial diversity in the bioremediation of environmental pollutants and the assessment of water quality. The great majority of microorganisms resists cultivation in the laboratory and thus, cannot be studied efficiently. Therefore, a major objective of Dr. Konstantinidis’ research program is to develop novel culture-independent (aka metagenomics and metatranscriptomics) approaches to study microbial communities in-situ, in both natural (e.g., terrestrial or marine) as well as human-associated systems.

Julia Oh, Ph.D., Assistant Professor, The Jackson Laboratory for Genomic Medicine

Dr. Julia Oh is an Assistant Professor at the Jackson Laboratory for Genome Medicine and a microbiome expert. Her current research focuses on technologies to explore and engineer the human microbiome, the communities of bacteria, viruses, and fungi that inhabit all areas of the human body and play an integral role in human health. She has significant training in genomics, genetics, and technology development, completing postdoctoral training at the National Human Genome Research Institute, her Ph.D. in genetics at Stanford University under renowned geneticist and technologist Ronald Davis, and her B.A. from Harvard University at the FAS Center for Systems Biology.

Katrine Whiteson, Assistant Professor, Molecular Biology & Biochemistry/Pediatrics, University of California, Irvine

Dr. Katrine Whiteson is interested in understanding how individual and persistent human-associated microbial and viral communities affect health. Infection with a bacterial pathogen, vaccination, immune development and even taking a Tylenol does not occur in a vacuum. Humans evolved in the presence of the dynamic microbial and viral communities that constantly inhabit our bodies, encoding the majority of unique metabolic genes. She studied Biochemistry at UC Berkeley (BA, 2000) and University of Chicago (PhD, 2007). During her PhD, Dr. Whiteson focused on the active site chemistry and DNA binding specificity of a site-specific recombinase from the class of proteins that enable the spread of antibiotic resistance genes. After working as a lecturer at UC Irvine for a year in 2007-2008, she moved to Geneva, Switzerland, and joined the Genomic Research Lab at the University of Geneva Hospitals with Dr. Jacques Schrenzel and Dr. Patrice Francois. This was an exciting era, just at the start of the Human Microbiome Project, for asking basic unanswered questions about the microbes and viruses inhabiting various niches of the human body. Dr. Whiteson focused on the oral microbial communities of healthy Europeans, and malnourished kids in Niger who develop a devastating facial gangrene known as noma. In 2011 she moved to Prof. Forest Rohwer’s lab at San Diego State, where she undertook breath and sputum metabolite analysis to better understand the activity of CF patient microbial communities from Dr. Doug Conrad’s Adult CF clinic at UCSD. Combining information about the genetic potential of a microbial community through DNA sequencing with the activity of the community by metabolite profiling is a powerful approach that Dr. Whiteson hopes to employ in future projects as she begins her own lab at University of California, Irvine.

Digital PCR

Sami S. Amr, Ph.D., FACMG, Associate Lab Director, Laboratory for Molecular Medicine, Partners HealthCare Personalized Medicine, Partners HealthCare

Dr. Sami Amr is a board-certified clinical molecular geneticist (American College of Medical Genetics) and is an Associate Director at the Laboratory for Molecular Medicine (LMM), a CLIA-certified laboratory offering clinical molecular genetics testing for several genetic diseases. In that capacity, Sami is involved in the development, validation, and reporting of clinical genetic tests across a variety of disease areas.

Kenneth D. Cole, Ph.D., Group Leader, Bioassay Methods, Biosystems and Biomaterials Division, National Institute of Standards and Technology

Laura Cavé, Sales Application Specialist, Application & Sales, Digital PCR Specialist, Stilla Technologies

Laura has worked many years in Molecular Biology for the development, optimization and validation of protocols in the field of Transcriptomics studies and Genomics with Digital PCR. She has worked in public sector labs and also in the private sector: Sanofi Pasteur and Biomérieux in France.

Kenneth Cole is the leader of the Bioassay Methods Group at NIST in the Biosystems and Biomaterials Division. The Bioassay Methods Group has programs in cancer biomarker standard development, quantitative flow cytometry for clinical measurements, cell line authentication measurements, fluorescence and UV absorbance standards, CHO cell genomics for biomanufacturing, and a new program in standards for gene editing measurements. We work with companies and other government agencies to improve the quality of measurements for research, production of biologicals, and healthcare applications.

Isaac Garcia-Murillas, Ph.D., Senior Scientific Officer, Breast Cancer Now Research Centre, The Institute of Cancer Research

Since 2010, Dr Garcia-Murillas has increasingly focused on translational research in breast cancer. He has led and developed work on the use of novel approaches, including Next Generation Sequencing (NGS) and digital PCR (dPCR) to study circulating tumour DNA (ctDNA) from “liquid biopsies”. Currently his research interests focus in the detection and tracking of structural variants, including gene amplifications and deletions, and mutations, primarily in breast cancer, but also in lung and Head and Neck cancers.

Randall T. Hayden, M.D., Director, Clinical and Molecular Microbiology, Department of Pathology, St. Jude Children’s Research Hospital

Dr. Hayden is Director of Clinical and Molecular Microbiology and Member in the Department of Pathology at St. Jude Children’s Research Hospital, in Memphis, Tennessee. He joined the faculty there in 2000, following post-doctoral training in microbiology and molecular microbiology at the Mayo Clinic and in surgical pathology at the MD Anderson Cancer Center. He is board certified in Anatomic and Clinical Pathology with sub-specialty certification in Medical Microbiology. His research interests focus on the application of molecular methods to diagnostic challenges in clinical microbiology, with particular emphasis on the diagnosis of infections in the immunocompromised host and standardization of viral load testing. He is editor-in-chief of Diagnostic Microbiology of the Immunocompromised Host, 2nd Edition; co-editor of Molecular Microbiology, Diagnostic Principles and Practice, 3rd Edition and of Medically Important Fungi, 6th Edition; and section editor for the Manual of Clinical Microbiology, 12th Edition, all from ASM Press. He serves as editor of the journal, Clinical Microbiology Reviews and associate editor for the Journal of Clinical Virology. He is president-elect of the Pan-American Society for Clinical Virology and also senior co-Chair and organizer of that society’s annual molecular virology workshop.

Rashmi Kanagal-Shamanna, M.D., Assistant Professor, Hematopathology, Molecular Pathologist, MD Anderson Cancer Center

Brett A. Kaufman, Ph.D., Associate Professor, Medicine, University of Pittsburgh

Brett Kaufman is an Associate Professor of Cardiology in the Center for Metabolism and Mitochondrial Medicine. His primary research is on mitochondrial biogenesis and mitochondrial genome stability. In this regard he has made significant scientific contributions to the fields of mitochondrial physiology, including the description of mitochondrial DNA-associated proteins (PNAS 2000; JCB 2003; Science 2005) and describing the mechanisms of mitochondrial genome compaction and stability (MBC 2007; BBA 2012; Mt 2016). Most recently, he has developed methods that describe changes in mitochondrial metabolism and damage that have been applied to oxidative damage and mitochondrial dysfunction (NAR 2013; FRBM 2014; SR 2016). His recent efforts in this field has been to develop quantitative reagents to study mitochondrial damage and generate mouse models via CRISPR reagents to study metabolism.

Raghu Mirmira, M.D., Ph.D., Lilly Professor of Pediatric Diabetes, Professor of Pediatrics, Medicine, Cellular & Integrative Physiology, Biochemistry & Molecular Biology; Director, Center for Diabetes and Metabolic Diseases; Director, Medical Scientist Training Program, Pediatrics, Indiana University

Raghu Mirmira received his bachelor’s, MD, and PhD degrees from the University of Chicago. During his PhD training, he worked under Howard Tager studying insulin-receptor interactions. After completion of his MD/PhD degrees, Dr. Mirmira subsequently completed his residency in Internal Medicine and subspecialty training in Diabetes and Endocrinology at the University of California at San Francisco. During his fellowship, Dr. Mirmira did his research training in the laboratory of Michael German, where he studied transcriptional regulation in the β cell. During this time, he held the prestigious Physician Postdoctoral Fellowship Award from the Howard Hughes Medical Institute, a JDRF Career Development Award, and later a Research Career Award from the National Institutes of Health. Dr. Mirmira then joined the faculty at the University of Virginia in 2000, where he studied several transcription factors that direct the development and function of beta cells. In addition, his research has more recently focused on mechanisms by which inflammation affects the islet β cell in type 1 diabetes mellitus.

Muhammed Murtaza, Ph.D., MBBS, Assistant Professor and Co-Director, Center for Noninvasive Diagnostics, Translational Genomics Research Institute

Dr. Muhammed Murtaza is an Assistant Professor at Translational Genomics Research Institute and Mayo Clinic in Arizona where he leads a research program focused on minimally-invasive cancer diagnostics using peripheral sampling. Before moving to TGen/Mayo in 2014, Dr. Murtaza received his medical degree (MBBS) from Aga Khan University in Karachi, Pakistan followed by a PhD from Trinity College and Cancer Research UK Cambridge Institute, University of Cambridge. At Cambridge, he worked with Dr. Nitzan Rosenfeld on developing diagnostics using circulating tumor DNA and published proof-of-principle studies describing tumor monitoring, genotyping and clonal evolution analysis using ctDNA.

Travis S. Schlappi, Ph.D. Candidate, California Institute of Technology

Travis Schlappi, M.S. is a 5th-year PhD student in Chemical Engineering in Professor Rustem Ismagilov’s research group at Caltech. For the past four years, he has been developing microfluidic tools and theory to enable diagnostic devices that detect pathogens without complex instrumentation or trained users. Currently, he is using those skills and collaborating with a team of chemists, biologists, and engineers to create a rapid diagnostic test that determines antibiotic susceptibility from a patient sample in less than 30 minutes.

Alexandra Whale, Ph.D., Senior Researcher, Molecular Biology, LGC

Alexandra is a Senior Researcher within the Nucleic Acid Research Group at LGC, the designated National Measurement Institute for chemical and bioanalytical measurements in the UK. Since joining in 2006, her research has focused on the use of digital PCR in a wide range of applications that include quantification and detection of DNA associated with microorganisms and antimicrobial resistance, and detection of copy number variation and rare sequences in cancer. Other areas of research have involved the use of dPCR as a method development tool to investigate sampling bias or reverse transcription efficiencies. She has extensive practical experience using different dPCR platforms and has giving a number of presentations at conferences and workshops on the experimental and analytical considerations needed for dPCR.

NGS for DNA Forensics

Cassandra D. Calloway, Ph.D., Assistant Scientist and DNA Program Coordinator, Genetics and Genomics and Forensic Graduate Program, Children’s Hospital Oakland Research Institute and University of California, Davis

Dr. Cassandra Calloway is an Assistant Scientist at Children’s Hospital Oakland Research Institute and Assistant Professor in the Department of Pediatrics in the School of Medicine at the University of California, San Francisco. She is also the DNA Program Coordinator for the Forensic Science Graduate Group and Assistant Adjunct Professor at the University of California, Davis. Dr. Calloway is a leader in the field of Forensic Genetics and has successfully developed several methods over the last 17 years for analyzing mitochondrial DNA (mtDNA) for human identification and casework currently used by forensic laboratories. Her research has primarily focused on the development of new genotyping assays for analysis of mtDNA and nuclear DNA markers for forensic human identification and clinical applications. Currently Dr. Calloway is leading an effort to develop sensitive methods for analysis of degraded and mixed DNA samples using next-generation sequencing (NGS) technologies for sequencing the entire mitochondrial genome and select nuclear SNP markers. She is also leading an effort to develop a probe capture NGS assay for noninvasive prenatal testing of beta-hemoglobinopathies.

Seth A. Faith, Ph.D., Assistant Professor, Forensic Sciences Institute, NC State University

Dr. Seth A. Faith joined NC State University in November 2014 as a Chancellor’s Faculty Excellence Program Cluster hire in DNA Forensics. Prior to joining NC State, he served as the technical leader in DNA forensics and genomics at Battelle Memorial Institute, a non-profit contract research organization, where he directed an interdisciplinary research portfolio sponsored by the US government and private industry. At Battelle he led several research and development (R&D) projects in human and microbial identification using next-generation sequencing technologies (NGS), advanced bioinformatics, and databasing. His R&D team was the first to publish a method for producing a full CODIS DNA profile with NGS technology that could be used for matching against the US national criminal database (NDIS). This project was later funded by the US Department of Defense to deploy a system to conduct DNA forensics with NGS. Dr. Faith also contributed to several teams that performed BioTerrorism Risk Assessment for the US Department of Homeland Security to assess the outcome and prevention of bioterrorism attacks on the United States. He is currently the principal investigator of the Genomic Identification Lab at NC State, where his continued research is focused on technology development to enhance global security. He is currently funded by the National Institute of Justice, Department of Defense, and collaborates with multiple state and federal law enforcement agencies for DNA technology development, cloud based computing, and data analytics. Dr. Faith is a member of several advisory bodies for the development of new forensic technologies including: the National Institute of Standards and Technology OSAC WF Subcommittee, the Federal Bureau of Investigation’s Scientific Working Group on DNA Analysis and Methods (SWGDAM), and the American Academy of Forensic Sciences Standards Board (ASB).

Ted Robert Hunt, J.D., Chief Trial Attorney, Prosecuting Attorney’s Office, Jackson County, Missouri

Ted R. Hunt is Chief Trial Attorney and DNA Cold Case Project Director at the Jackson County Prosecutor’s Office in Kansas City, Missouri. He has been a prosecuting attorney for 25 years. In that time, Mr. Hunt has prosecuted well over 100 felony jury trials, the vast majority of which have involved the presentation of DNA and other forensic evidence. In his current capacity, Mr. Hunt manages all general trial attorneys in his office and serves on the Capital Case Review, Homicide, and Police Shooting Review Committees. Mr. Hunt is a member of the National Commission on Forensic Science, the Missouri Crime Laboratory Review Commission, and the Legal Resource Committee for the Organization of Scientific Area Committees (OSAC), serving as the prosecutor liaison to the Biology/DNA Scientific Area Committee. He also serves as a Member of the ANAB Accreditation Council, the International Association of Chiefs of Police (IACP) Forensic Science Committee; the National District Attorney’s Association’s DNA Advisory Group; is an invited guest on the Next Generation Sequencing Working Group at SWGDAM; and is a Member of the Friction Ridge Consensus Body of the American Standards Board. Mr. Hunt is a Fellow in the American Academy of Forensic Sciences, an Associate Member of the Midwest Association of Forensic Scientists, and is a Member of the Bar in the States of Missouri and Kansas.

Jodi Irwin, Ph.D., Research Scientist, DNA Support Unit, FBI Laboratory

Jodi Irwin is a Research Scientist at the FBI Laboratory where, for the past four years, she has supported DNA casework by optimizing and streamlining mitochondrial DNA workflows, and performing research to advance the FBI Laboratory’s NGS initiatives. Prior to joining the FBI, she spent 14 years at the Armed Forces DNA Identification Laboratory where she directed NGS initiatives, developed automated solutions for sample processing, programmed bioinformatics algorithms and applications for database searching and kinship statistics, and developed novel methods/technologies to expand the AFDIL’s DNA testing capabilities. Her early career was spent in a number of academic laboratories focused on ancient DNA and evolutionary genetics. She has a B.S from the University of Notre Dame, a M.S. from San Francisco State University and a Ph.D. from the University of Innsbruck.

Kenneth K. Kidd, Ph.D., Professor Emeritus, Genetics, Yale University School of Medicine

Kenneth K. Kidd received his Ph.D. in Genetics from the University of Wisconsin in 1969. His early training included Drosophila genetics, classical immunogenetics, and population genetics. During his post-doctoral studies in Italy and at Stanford University, he established his reputation in human population genetics. He joined the Genetics faculty at Yale University School of Medicine in 1973 where he has remained and is currently Professor of Genetics, Psychiatry, and Ecology and Evolutionary Biology. At Yale, he has pursued research in many areas of human genetics, including medical genetics (studies of neuropsychiatric disorders and simple Mendelian disorders), gene mapping (both physical and genetic), database design for modern genetic data, and a variety of molecular methodologies. More recently, his long-standing interest in human population genetics has been combined with his laboratory's expertise in molecular technology to examine human genome diversity at the DNA level. He is also responsible for ALFRED, the ALlele FREquency Database, a web accessible compilation of allele frequency data for DNA polymorphisms on anthropologically defined human population. During his career, Dr. Kidd has published more than 450 scientific articles in a broad range of subjects including population genetics, cancer and neuropsychiatric genetics, gene mapping, molecular methodology, genetic databases, and human diversity. He is one of the co-authors of a paper selected as the best biomedical paper of the year by The Lancet, a leading British medical journal. This and other publication by Dr. Kidd can be found on his website http://info.med.yale.edu/genetics/kkidd. He is a certified Medical Geneticist by the American Board of Medical Genetics. He has served on several U.S. Government Review and Advisory Committees/Panels, on several editorial boards, and helped organize several international conferences. He is a member of several professional societies and a Fellow of the American Association for the Advancement of Science. Among his other awards, he has been recognized by the U.S. Federal Bureau of Investigation and the National Institute of Justice for his contributions toward acceptance of DNA methodologies in the courts. He recently served on national advisory panels for DNA identification of victims of the World Trade Center attack and victims of Katrina.

Steven Lee, Professor, Justice Studies; Director, Forensic Science Justice Studies, San Jose State University

Professor Lee holds a BS from SUNY Binghamton in Biology, MS from NYU and Ph.D. from University of California, Berkeley in Molecular Biology. Lee holds several concurrent positions including consulting positions for several biotech companies, Visiting Scholar at UC Berkeley, and an adjunct professor appointment in Chemistry at Florida International University and in Biological Sciences at San Francisco State University. Lee is currently on 50% Professional Leaves for AY 2015-2016 and is teaching on line. He was formerly the Director of R&D at CA Dept of Justice DNA Laboratory from 1994-2000 where he served as an expert witness in DNA, directed the development, validation and implementation of new technologies and, conducted DNA training courses. He is a full member of the American Association for the Advancement of Science, the California Association of Criminalists, a Fellow of the Criminalistics Division of the American Academy of Forensic Sciences, and is an American Society of Crime Laboratory Directors Laboratory Accreditation Board certified inspector. He also served on the FBI Technical Working Group on DNA Analysis Methods group from 1994-2000. He has taught courses in molecular biology at SFSU (1996-1998), Forensic genetics at UC Davis (1997), and most recently forensic DNA Typing of STRs at FIU (2003).

Joseph Ring, MS, DNA Analyst, Emerging Technology Section-AFDIL, Contractor; ARP Sciences LLC a Division of ARP, Supporting the Armed Forces Medical Examiner System

No bio available.

Julie Conover Sikorsky, M.S., F-ABC, Forensic Biology Unit Manager, Palm Beach County Sheriff’s Office

Julie Sikorsky has been employed by the Palm Beach County Sheriff’s Office for almost fifteen years and is currently the manager of the Forensic Biology Unit. Prior to becoming a manager, Julie was a full-time DNA caseworking analyst for over ten years. She has actively worked hundreds of forensic DNA cases and regularly offers expert witness testimony. She obtained a bachelor’s of science degree in molecular biology from the University of California at San Diego and two master’s degrees from Marshall University in Huntington, West Virginia, one in forensic science the other in biomedical sciences. Julie is a certified Fellow of the American Board of Criminalistics (ABC) in molecular biology, and holds memberships in: the American Academy of Forensic Sciences (AAFS), the International Society for Forensic Genetics (ISFG), and the American Society of Crime Laboratory Directors (ASCLD). She is also a certified technical assessor for ASCLD/LAB – International and peer reviews articles for the journals Forensic Science International: Genetics and Forensic Science Policy & Management.

Mark Wilson, Ph.D., Research Leader, Applied Genomics, Battelle Memorial Institute

Wilson holds a duel B.S. in Biology and Chemistry from Azusa-Pacific College, an M.S. in Biology from California State University, Fullerton, and a Ph.D. in Biosciences from George Mason University.

Elisa Wurmbach, Ph.D., City Research Scientist, Forensic Biology, Office of Chief Medical Examiner, New York

No bio available.

Non-Invasive Prenatal Testing

Art Beaudet, M.D., Department of Molecular & Human Genetics, Baylor College of Medicine

Dr. Beaudet received his M.D. degree from Yale, did pediatric residency training at Johns Hopkins, and was a research associate at the National Institutes of Health before joining Baylor College of Medicine (BCM) in 1971 where he has remained to the present. Dr. Beaudet has made diverse contributions in the field of mammalian genetics including discovery of uniparental disomy in humans, identification of the Angelman syndrome gene, recognition of a novel inborn error of carnitine biosynthesis as a risk factor for autism, developing cell-based noninvasive prenatal testing, and publishing over 300 original research articles. Dr. Beaudet is well-known as one of the editors of the Metabolic and Molecular Bases of Inherited Disease textbook for the 6th through 8th editions and now the electronic edition, and he has served on many editorial boards and national review panels. He was President of the American Society of Human Genetics in 1998 and is an elected member of the Association of American Physicians, the National Academy of Medicine (formerly Institute of Medicine), and the National Academy of Sciences. Dr. Beaudet is currently the Henry and Emma Meyer Distinguished Service Professor in the Department of Molecular and Human Genetics

Peter Benn, Ph.D., Department of Genomics and Genome Sciences, University of Connecticut Health Center

Peter Benn completed his undergraduate degree at the University of St Andrews, Scotland, received a PhD from the University of Birmingham, England, and post-doctoral training at the University of Pennsylvania. He also holds a DSc degree from the University of St Andrews. For the past 25 years he has been a faculty member at the University of Connecticut Health Center and is currently a tenured professor in the Department of Genetics and Genome Sciences. Clinical responsibilities have included oversight of the cytogenetics and prenatal screening laboratories. His research interests have focused on prenatal testing and diagnosis, most recently involving the introduction of non-invasive prenatal testing. Dr Benn is chair the International Society for Prenatal Diagnosis (ISPD)’s Special Interest Group (SIG) for Prenatal Screening. He has Chaired ISPD’s Committee for Chromosome Abnormality Screening which developed Position Statements for non-invasive prenatal screening.

Katie Carlberg, M.D., Clinical Hematology Oncology Fellow, Children’s Hospital Oakland Research Institute

Dr. Katie Carlberg is a currently a Pediatric Hematology Oncology Fellow at UCSF Benioff Children’s Hospital, Oakland. She received her medical degree at SUNY Upstate Medical University and completed her Pediatric residency at University of Wisconsin, Madison. She has a passion for Global Health and has been fortunate to have had the opportunity to travel to The Domincan Republic, Uganda, and India during her training in order to gain a better appreciation for the determinants of health in these settings. Dr. Carlberg has a particular interest in benign hematology as well as transfusion medicine. During her fellowship she has been working with Dr. Cassandra Calloway on a project to develop a noninvasive prenatal test for β-hemoglobinopathies using probe capture and NGS for the analysis of cell-free DNA in maternal plasma. The purpose of this research will be to advance the fund of knowledge in order to achieve better patient care and outcomes for the millions of people around the world with hemoglobinopathies.

Megan H. Cleveland, Ph.D., Research Biologist, Applied Genetics Group, National Institute of Standards and Technology (NIST)

Megan received a Ph.D. in Human Genetics from Johns Hopkins School of Medicine in 2014. At NIST, Megan is developing clinical standards related to genetic testing techniques such as digital PCR and next-generation sequencing. Additionally, she is working with the Genome in a Bottle (GiaB) consortium to examine results from targeted sequencing panels on GiaB benchmark genomes.

Mark Evans, M.D., President, Fetal Medicine Foundation of America; Professor of Obstetrics and Gynecology, Mt. Sinai School of Medicine; Comprehensive Genetics

Dr. Evans has been the Charlotte B. Failing Endowed Chair and Distinguished Professor of Obstetrics & Gynecology, Professor of Molecular Medicine and Genetics, and Professor of Pathology at Wayne State University; Professor and Chairman of Obstetrics & Gynecology at MCP Hahnemann University; and is currently Professor of Obstetrics & Gynecology at Mt. Sinai School of Medicine. He has won multiple national research awards including the President's award for achievement by the Society for Gynecologic Investigation, and awards for the protection of women's rights from the National Organization for Women and Planned Parenthood and the Lifetime Achievement Award from the International Fetal Medicine and Surgery Society.

Luis Gomez, M.D., Assistant Professor, Division of Maternal Fetal Medicine, Perinatal Associates of Northern Virginia

Dr. Gomez attended Medical School in Lima, Peru (Universidad Nacional Mayor de San Marcos). He spent his residency in Obstetrics and Gynecology at the Hospital San Bartolome, in Lima, Peru and the Eastern Virginia Medical School, Norfolk VA. His Fellowship in Maternal Fetal Medicine was at the University of Pennsylvania. He received his Masters of Science in Epidemiology from University of Tennessee Health Science Center.

Tony Jun Huang, Ph.D., Professor, Mechanical Engineering and Materials Science (MEMS), Duke University

Tony Jun Huang is a professor at Department of Mechanical Engineering and Materials Science (MEMS) at Duke University. Previously he was a professor and The Huck Distinguished Chair in Bioengineering Science and Mechanics at The Pennsylvania State University. He received his Ph.D. degree in Mechanical and Aerospace Engineering from the University of California, Los Angeles (UCLA) in 2005. His research interests are in the fields of acoustofluidics, optofluidics, and micro/nano systems for biomedical diagnostics and therapeutics. He has authored/co-authored over 180 peer-reviewed journal publications in these fields. His journal articles have been cited more than 9000 times, as documented at Google Scholar (h-index: 52). He also has 17 patents and invention disclosures. He was elected a fellow of the following five professional societies: the American Institute for Medical and Biological Engineering (AIMBE), the American Society of Mechanical Engineers (ASME), the Institute of Electrical and Electronics Engineers (IEEE), the Institute of Physics (IOP), and the Royal Society of Chemistry (RSC). His work have been recognized with awards and honors such as a 2010 National Institutes of Health (NIH) Director’s New Innovator Award, a 2011 Penn State Engineering Alumni Society Outstanding Research Award, a 2011 JALA Top Ten Breakthroughs of the Year Award, a 2012 Outstanding Young Manufacturing Engineer Award from Society for Manufacturing Engineering, a 2013 Faculty Scholar Medal from The Pennsylvania State University, a 2013 American Asthma Foundation (AAF) Scholar Award, and the 2014 IEEE Sensors Council Technical Achievement Award from The Institute of Electrical and Electronics Engineers (IEEE).

Michael Lutz, Ph.D., CEO, LifeCodexx AG

Michael. Lutz has many years of experience in establishing and leading innovative biotechnology companies. He has been Chief Executive Officer of LifeCodexx AG since 2010. Since 2005, he has successfully established six international biotech companies. Before that, Dr. Lutz spent many years at Novartis Pharma and Evotec in various management positions. He studied chemistry and biochemistry in Germany and France and received his Ph.D from the ETH Zurich (Switzerland).

Glenn E. Palomaki, Ph.D., Professor, Pathology and Laboratory Medicine, Women & Infants Hospital/Alpert School of Medicine at Brown University

Glenn E. Palomaki, PhD is an Associate Director of the Division of Medical Screening and Special Testing at Women & Infants Hospital and a Professor in the Department of Pathology and Laboratory Medicine at the Alpert Medical School of Brown University. His main research interests are the statistical and methodological evaluations of screening and diagnostic tests. He has conducted multiple external validation studies demonstrating the screening or diagnostic performance of tests for genetic disorders as well as chronic diseases. He has led structured evidence reviews funded by the Centers for Disease Control and Prevention and provided statistical analyses for several other agencies. Dr. Palomaki has served on the Quality Assurance Committee of the American College of Medical Genetics where he helped author multiple laboratory standards and guidelines. Currently, he is a member of the Molecular and Biochemical Genetics Resource Committee of the College of American Pathologists and is involved in developing external quality assessment for next generation sequencing of cell free DNA in maternal circulation to identify common fetal aneuploidies. Since 2006, Dr. Palomaki has authors or co-authored 107 peer-reviewed articles and made 38 national and 22 international invited presentations. During that same time period, he has been (is) PI or Co-PI on several large industry-sponsored but independent clinical trials of screening for fetal aneuploidy using cell free DNA in maternal circulation.

David Peters, Associate Professor, Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh

Research at David Peters’s lab is built around two related themes. The first is the development of non-invasive diagnostic tests for fetal genetic disease. The second is the analysis of epigenetic changes associated with normal development and reproductive disease. To achieve these goals, the lab combines high-throughput methods in genomics with computational methods.

Hsian-Rong Tseng, Ph.D., Professor, Department of Molecular and Medical Pharmacology, University of California, Los Angeles

Dr. Tseng is currently a Professor in the Department of Molecular & Medical Pharmacology in David Geffen School of Medicine at UCLA. He also holds memberships in the California NanoSystems Institute, Crump Institute for Molecular Imaging, and Jonsson Comprehensive Cancer Center on the UCLA campus. With continuous support from NIH, his research team has built a unique rare-cell sorting method (a.k.a., NanoVelcro Assays) that enables detection, isolation, and characterization of circulating tumor cells (CTCs) in peripheral blood of cancer patients. Over the past decade, their joint research endeavors have led to a series of NanoVelcro CTC Assays, which have been used to explore the full potential of CTCs as a clinical biomarker, including CTC enumeration, phenotyping, genotyping and expression profiling. To facilitate the commercial transition of the NanoVelcro Assays, Dr. Tseng founded CytoLumina Technologies Corp., a biotechnology company that has licensed intellectual properties associated with NanoVelcro Assays from UCLA. The company is on a mission to make dramatic improvements in cancer patient quality of life through its patented high sensitivity liquid biopsy nanotechnology for cancer detection and monitoring. CytoLumina’s CTC enumeration assay is currently undergoing an FDA 510(k) medical device clearance for prognostic utility in prostate cancer. In December 2016, CytoLumina was officially invited to participate in White House Cancer Moonshot’s Blood Profiling Atlas in pursuit of accelerating blood profiling diagnostic technologies for the benefit of patient quality of life.

Emerging Cancer Biomarkers

Muller Fabbri, M.D., Ph.D., Assistant Professor, Pediatrics and Molecular Microbiology & Immunology, Pediatric Hematology/Oncology, Children’s Hospital Los Angeles - University of Southern California

Dr. Muller Fabbri is Assistant Professor of Pediatrics and Molecular Microbiology and Immunology at Children’s Hospital Los Angeles (CHLA), Keck School of Medicine of the University of Southern California. Dr. Fabbri has provided the first evidence of the existence of epi-miRNAs, and has described a complex miRNA-based network responsible for the prognostic significance of chromosomal aberrations in chronic lymphocytic leukemia. More recently, Dr. Fabbri has identified a completely new mechanism of action for miRNAs as ligands of Toll-like receptors. Dr. Fabbri is author of more than 60 peer reviewed publications, he has authored several book chapters, serves in the Editorial Board of 6 international scientific Journals. Dr. Fabbri’s lab at CHLA is focused on studying how microRNAs (and other non-coding RNAs) are communicating between cancer cells and surrounding cells of the tumor microenvironment and how this affects cancer biology and the development of resistance to chemo and radiotherapy.

Bernard A. Fox, Ph.D., Harder Family Chair for Cancer Research, Member & Chief, Laboratory of Molecular & Tumor Immunology, Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute, Providence Cancer Center; CEO, UbiVac

Dr. Fox has spent more than 30 years studying how to use a patient’s immune system to fight cancer. He is an internationally recognized leader in immuno-oncology and co-founder and CEO of UbiVac. Dr. Fox has participated in and led both preclinical and clinical studies of cancer immunotherapy. Building on the most recent advances in immunology and autophagy, Dr. Fox is leading the charge to utilize the disruptive innovation of UbiVac’s next generation vaccine technology to advance treatments for patients with cancer of the lung, breast, prostate, colon, head and neck and pancreas. He is also driving UbiVac’s efforts, in collaboration with Janssen Biotech, to develop vaccines that intercept or prevent cancer. Dr. Fox also holds the Harder Family Chair for Cancer Research, at the Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute, Providence Health and Services and is on faculty at Oregon Health and Science University School of Medicine. Dr Fox is a member of the Knight Cancer Institute and the Providence Cancer Center. His background in translational cancer immunotherapy developed from his tenure as a fellow in Dr. Steven Rosenberg’s lab at the National Cancer Institute. In addition to training a next generation of scientists and physicians, Dr. Fox is the current Chair of the World Immunotherapy Council, a consortium of 22 national and international cancer immunotherapy organizations and a past President of the Society for Immunotherapy of Cancer. He has published more than 130 manuscripts and book chapters, served on review committees for the NIH, FDA, philanthropic and governmental organizations in the USA, Europe and Asia, and serves on editorial boards of several scientific journals. Dr. Fox served on the board of directors of NeoPharm from 2004 to 2010, and is currently on the board of directors of the Oregon Bioscience Association. In 2011, Dr. Fox co-founded UbiVac-CMV, to develop cytomegalovirus vectors as vaccines for cancer. Dr. Fox lectures widely and serves on advisory boards for a number of biotechnology and pharmaceutical companies. In 2015, Dr. Fox received the Visionary/Legacy Award from the Society for Immunotherapy of Cancer (SITC).

Manuel Fuentes, Ph.D., Scientist, Medicine and Proteomics Unit, Cancer Research Center. University of Salamanca-CSIC

Manuel Fuentes graduate in Chemistry and Biochemistry by the University of Salamanca (Spain). After his Master in Biotechnology at University of Bielefeld (Germany), he joined at Biocatalysis Department at National Spanish Research Council (Madrid, Spain) for his PhD Thesis, entitled “Design and development of conjugation and immobilization methods of biomolecules for diagnostic methods useful in Genomics and Proteomics”. Afterwards, he moved to Harvard Institute of Proteomics at Harvard Medical School ( Boston, EE.UU.), during almost 8 years, when he was working on biomarker and drug discovery in tumor and autoimmune pathologies by using a combination of high-throughput proteomics approaches. In 2010, he joined as a scientist at Cancer Research Center at University of Salamanca, where his research is focused on biomarker and drug discovery in hematological diseases, mainly for personalized medicine. Manuel Fuentes is co-author of 100 peer-reviewed papers ( ISI web of Knowledge) in international journals, >10 licensed international patents, >15 book chapters, and more than 50 invited lectures in national and international meetings. In 2010, Human Proteome Organization awarded Manuel Fuentes as “HUPO Young Scientist" for his highly-relevant contributions in the field.

Christos Hatzis, Ph.D., Assistant Professor of Medicine, Internal Medicine, Section of Medical Oncology, Yale School of Medicine

Dr. Hatzis has 20 years of experience in senior research and management roles in biocomputational techniques, systems biology modeling, genomic analysis and clinical diagnostics. He received his Ph.D. from the University of Minnesota and held several senior research roles in the biotechnology industry. He has been the cofounder of two startup companies specializing in bioinformatics tools development and in clinical diagnostics. Dr. Hatzis had been an active member of the Biostatistics committee of FDA's Microarray QC program, co-investigator on the NCI Cancer Biospecimen Integrity program and co-investigator on serveral studies by Breast Cancer Foundations. Among his most significant contributions are the co-development with colleagues from MD Anderson of the RCB index, a continuous index of residual disease in breast cancer, and the development of a gene-expression based prognostic signature for patients treated with standard chemotherapy that accounts for phenotypic differences and integrates endocrine sensitivity, and chemotherapy response and resistance endpoints. Dr. Hatzis continues to be involved in the design of biomarker validation clinical studies and development of strategies for translating genomic diagnostic assays to clinical practice. His current research interests focus on developing methods to characterize the genetic and molecular heterogeneity of breast cancer subtypes and the implications it might have on response and resistance to treatment. A key area of interest is to develop methodology that integrates genomic level information of individual patients to lead to more focused treatment decisions tailored for the individual tumor. Dr. Hatzis is serving as academic editor on biomarker journals, has been a reviewer on NCI and NSF panes and is serving as ad-hoc reviewer on several bioinformatics and clinical journals.

Tony Y. Hu, Ph.D., Associate Professor, Biodesign Institute, Arizona State University

Tony Hu is an Associate Professor at the Biodesign Institute at Arizona State University’s Virginia G. Piper Center for Personalized Diagnostics and at ASU’s School of Biological and Health Systems Engineering. Dr. Hu’s research focuses on developing and validating integrated nanotechnique-based strategies for marker discovery and molecular diagnostics in peripheral blood samples to provide a translatable solution for personalized medicine. His innovations aim to fill current gaps in early detection, real-time therapy monitoring and effective prognostics. He has assembled a diverse team with backgrounds in biochemistry, mass spectrometry, nanofabrication, and biomedical engineering to answer these needs. Dr. Hu received his Ph.D. in Biomedical Engineering from the University of Texas at Austin where he focused on developing nanomaterials as biosensors for disease diagnosis. He has published more than 50 journal articles and has received five U.S. patents (issued and pending) on these subjects since his first faculty appointment in 2011. Dr. Hu has also published four nanomedicine-related book chapters, and has given more than 40 seminars and invited presentations at major international scientific conferences. His research team has a history of grants from the NCI, NIAID, NICHD and DOD and awards from the Gates, Dunn, Kostas, and Cockrell family foundations. His team has in-depth knowledge of multiplex-detection method development for sample processing, mass spectrometry, biomarker identification and validation. This background ideally positions his team for a leadership role in these fields and for optimal clinical translation of their platforms for improved and comprehensive analysis of blood-based biomarkers that have broad potential clinical applications.

Upender Manne, MS., PhD., Professor , Pathology, University of Alabama at Birmingham

Dr. Upender Manne is a Professor of Pathology and Surgery, and a Senior Scientist at the National Institute of Health (NIH)-designated Comprehensive Cancer Center of the University of Alabama at Birmingham (UAB CCC), Alabama. He is also a Senior Scientist at the Minority Health Disparity Research Center at UAB. His scientific career has been dedicated to translational pathology research on human malignancies. His research has centered on tumor molecular biology; cancer genetics; development of methodological techniques; discovery and validation of cancer markers for early detection, risk, prognosis, and prediction; and racial disparities in the biology, epidemiology, and pathology of colorectal, breast, and prostate cancers. His current efforts are directed towards conducting molecular correlative studies as part of clinical trials and investigator initiated biomarker-based clinical trials. These studies will aid in the development of molecular assays that relate to early detection, diagnosis, prognosis, and precision cancer medicine. He is an expert and leader in the field of Cancer Biomarkers. He currently serves as a lead principal investigator of two large multiinstitutional grants, funded by the National Cancer Institute of the NIH. Dr. Manne serves as one of the Editors of Molecular Cancer Biology, as an Associate Editor of PLoS ONE and BMC cancer, as well as serves on editorial boards of seven other scientific journals. He also serves on various NIH oncology study sections. He has published more than 100 peer-reviewed scientific articles. To the present time, he has mentored more than 45 undergraduate, medical, and graduate students; 6 residents; 8 clinical fellows; and 16 postdoctoral fellows. His mentoring skills were recognized by a Sir Charles Barkley Mentoring Excellence Award. Also, in 2009, he was invited by the US Presidents Cancer Panel to deliver a lecture on how racial/ethnic admixtures affect the findings of molecular biomarker studies (tumor profiling) relating to cancer outcomes. He conducted several international workshops and headed sessions at internal conferences.

Stephen J. Murphy, Ph.D, Research Scientist, Biomarker Discovery Program, Center for Individualized Medicine, Mayo Clinic

My enthusiasm for research has always been driven by a need to provide improvements for patient clinical care and treatments. The amazing pace with which technology is advancing to enable understanding and diagnosis of disease at the genetic level is providing the tools to revolutionize patient management. Through my PhD studies at Royal Holloway college London and extensive research experience in the fields of gene therapy, cell signaling and clinical genomic analysis, I have attained a wide range of technical expertise in this field of study. My initial research experience in gene therapy provided me with molecular biology and cell culture techniques, focused on the design and construct adenoviral vectors for in vitro and in vivo use. My transition into cell signaling research, specifically on the TGF-beta network, expanded my technical repertoire in detailed protein analysis and mechanistic interactions, as well as cell imaging by confocal microscopy, specifically in the field of polarized epithelial trafficking. My current research in the field of clinical genomic analysis, focused on prostate, lung and pancreatic cancers, has provided me with extensive experience in extraction and purification of DNA and RNA from clinical specimens. To this goal I have developed a number of methodologies for the extraction of genomic material from minute clinical specimens and refined methodologies to amplify this material for application to high throughput next generation sequencing platforms; including Paired-End, Mate-Pair, Exome Capture and RNAseq.

George J. Netto, M.D., Professor and Chair, Department of Pathology, University of Alabama at Birmingham

George J. Netto, M.D. is Professor and Chair of Pathology at The University of Alabama at Birmingham (UAB). Prior to joining UAB, Dr. Netto was a Professor of Pathology, Urology and Oncology at Johns Hopkins University where he served as the director of Surgical Pathology Molecular Diagnostics. Dr. Netto is recognized throughout the United States and around the globe for his expertise as a clinician, scholarly educator, and physician-scientist whose research is focused on urologic and molecular diagnostic pathology. He is associate editor of the Vircow Archives European Journal od Pathology , associate editor for translation and basic science for the journal “Urology” and the associate editer for the journal “Urology Case Report” and serves on the editorial boards of the journals of “Human Pathology”, “Pathology” and “Advances in Anatomic Pathology”. He has authored or co-authored over 300 articles which have been published in peer-reviewed medical journals. He has co-authored four books in urologic pathology and is the editor of a widely recognized textbook on genomics in pathology titled “Genomic Applications in Pathology”. Dr. Netto is frequently requested to speak at national and international lectures in the fields of urologic oncology and molecular and genomic diagnostics.

Jason N. Rosenbaum, M.D., Assistant Professor, Department of Pathology and Laboratory Medicine, Center for Personalized Diagnostics, University of Pennsylvania, Perelman School of Medicine

Jason N. Rosenbaum is an Assistant Professor at the University of Pennsylvania, Perelman School of Medicine in the Department of Pathology and Laboratory Medicine. Jason recently completed his fellowship in Molecular Genetic Pathology at the Washington University School of Medicine in St. Louis, and his residency at the University of Wisconsin Hospital and Clinics in Madison, Wisconsin. Jason is certified in molecular genetic pathology, as well as anatomic and clinical pathology by the American Board of Pathology. Jason attended the Northwestern University Feinberg School of Medicine, earning his MD in 2011. There he did research into the embryonic development and evolution of the nervous system. In 1998, he graduated with honors from the University of California at Berkeley, with a double major in Molecular Biology (Genetics focus) and Integrative Biology (Evolution focus).

George Vasmatzis Ph.D., Director, Biomarker Discovery Program, Center For Individualized Medicine, Molecular Medicine, Mayo Clinic

Dr. George Vasmatzis is the director of the Biomarker Discovery Program, within the Center for Individualized Medicine, and his research program consists of bioinformatics specialists, molecular biologists, epidemiologists, and pathologists. He is a Consultant in the Department of Molecular Medicine and a member of the Mayo Clinic Cancer Center. He is also an Assistant Professor in the Department of Laboratory Medicine at the Mayo Medical School. He has a Ph.D. in Biomedical Engineering and has acquired experience in diverse disciplines, including Bioinformatics, Molecular Biology, and Computational Biology. His laboratory has demonstrated success in discovery and translation of several biomarkers as well as developing evidence-based models that should help clinicians stratify (cancer) patients in order to provide each individual with the appropriate care.